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October 2011, Volume 15,
Number 5
Article
Putting Evidence Into Practice:
Evidence-Based Interventions for Radiation Dermatitis
Deborah Feight,
RN, MSN, AOCN®, CNS, Tara Baney, RN, MS,
CRNP, ANP-BC, AOCN®,
Susan Bruce, RN, MSN, OCN®,
CNS, and Maurene McQuestion,
RN, BScN, CON(C), MSc
Radiation dermatitis, or radiodermatitis, is a significant symptom caused by
radiation therapy for the treatment of cancerous and noncancerous conditions. Radiodermatitis can negatively affect patients’ physical
functioning and quality of life. The Oncology Nursing Society coordinated a
Putting Evidence Into Practice (PEP) project team to develop a PEP resource
summarizing current evidence for the management of patients with radiodermatitis. Oncology nurses play an important role in
educating, assessing, and monitoring patients for this symptom. Many common
nursing interventions for radiodermatitis are based
on tradition or opinion and have not been researched thoroughly. In addition,
evidence to support some current interventions in practice is lacking. This
article presents information concerning radiodermatitis,
summarizes the evidence-based review for its prevention and management, and
identifies gaps in the literature, as well as opportunities for research,
education, and practice.
At a Glance
¨ Radiodermatitis is associated with the integumentary system response to a planned exposure of
ionizing radiation, which depletes stem cells from the basal layer of the
epidermis.
¨ Current evidence-based
interventions recommended for practice include intensity-modulated radiation
therapy and usual hygiene practices such as washing the irradiated skin and the
use of mild soaps and deodorants.
¨ A wide variety of treatments
currently in use have not demonstrated effectiveness in randomized, controlled
studies, highlighting a need for research to guide evidence-based practice in
this area.
Radiodermatitis, also known as radiation dermatitis or radiation skin reaction, is
caused by the changes cells undergo in the basal layer of the epidermis and the
dermis (Wickline, 2004). Cumulative daily doses of
radiation to the treatment field, including doses deposited to the skin,
prevent normal skin cells from repopulating immediately, which weakens skin
integrity in the radiation field. In countries such as the United States,
Canada, Europe, and Australia, at least 50% of patients diagnosed with cancer
will receive radiation therapy during their illness (Bernier et al., 2008). Up
to an estimated 95% of patients receiving radiation therapy will experience
some degree of skin reaction, which may include erythema,
dry desquamation, and moist desquamation (De Conno, Ventafridda, & Saita, 1991;
King, Nail, Kreamer, Strohl,
Johnson, 1985; Porock & Kristjanson,
1999) (see Table 1). The true incidence of radiodermatitis
resulting from new technologies along with the increased use of multimodality
therapy is not known (Bernier et al., 2008; Hymes,
Strom, & Fife, 2006; Pignol et al., 2008). The
effects of radiodermatitis can impact a patient’s
quality of life, cause pain and discomfort, limit activities, and delay
treatment (Aistairs, 2006). Radiodermatitis
also may cause interruption in or cessation of treatment, depending on the
severity of reaction.
Although avoidance of skin reactions caused by radiation therapy would be
preferred, it often is not possible, such as in treatment for inflammatory
breast cancer where an intense skin reaction is expected. Therefore, delay and
reduction in severity of radiodermatitis is the goal,
not total elimination (Primavera et al., 2006). Various products for prevention
or management of radiodermatitis have limited
evidence or consensus to support their use (Bolderson,
Lloyd, Wong, Holden, & Robb-Blenderman, 2005).
Although limited evidence supports the use of general measures such as washing
with mild soap and water, keeping the treatment area clean and dry, wearing
loose-fitting clothes, and protecting the radiation area from irritants, those
measures have been found to be anecdotally effective (Omidvari
et al., 2007).
Several factors can be attributed to the varying response of patients’ skin to
radiation therapy. Treatment-related factors such as individual fraction size,
type of energy, and the use of bolus doses can impact skin reactions. Host
factors also may play a role in the development of radiodermatitis;
they may include genetic factors, personal factors (e.g., areas of skin
friction), existing skin integrity issues, comorbid
conditions, nutritional status, age, race and ethnicity, medications, sun
exposure, smoking, and mobility (Ryan et al., 2007). The relationship between
those factors must be considered when identifying patients at greater risk for
impaired skin integrity because of radiation therapy.
Late skin changes also may be seen in patients who have received radiation
therapy. The changes may appear several months to years after radiation therapy
has been completed. Changes in skin pigmentation are caused by radiation’s
damaging effects to melanocytes. Telangectasia
results from damage and stretching of the capillaries, commonly found with
moist desquamation during the acute phase of radiodermatitis.
Fibrosis may be one of the most debilitating late changes that can occur.
Fibrosis is caused by excessive extracellular matrix and collagen deposits
occurring because of the inflammatory response, with changes in the
proliferative and tissue remodeling phases of wound healing following radiation
therapy. Fibrosis can lead to decreased tissue flexibility causing reduced
range of motion, strictures, atrophy, and reduced tissue strength. Finally,
although rare, patients are at increased risk for delayed wound healing,
dehiscence, fistula, tissue graft failures, and other surgical complications
within a radiation treatment field (Bentzen, 2006; McQuestion, 2010).
Unfortunately, research determining appropriate methods for prevention or
treatment of late radiation skin changes is lacking. Anecdotal evidence
suggests that intensity-modulated radiation therapy (IMRT) may decrease the
incidence of late effects. One study reviewed the use of IMRT in patients with
breast cancer and showed a decrease in severity and duration of moist
desquamation (Freedman et al., 2009). One may extrapolate a potential for
decreased late effect skin changes, but this was not an endpoint of the study.
To date, available literature does not address interventions for late effect
management, other than massage in women with fibrosis caused by breast
radiation (Bourgeois, Gourgou, Kramar,
Lagarde, & Guillot,
2008).
Assessment Tools and Grading Scales
Commonly
used grading or scoring tools for assessment and documentation of radiodermatitis include the Radiation Therapy Oncology
Group (RTOG) Acute Radiation Morbidity Scoring Criteria (Cox, Stetz, & Pajak, 1995); the
RTOG/European Organization for Research and Treatment of Cancer (EORTC)
toxicity criteria (Cox et al., 1995); the Common Terminology Criteria for
Adverse Events, version 4.03 (CTCAE) (National Cancer Institute Cancer
Therapy Evaluation Program, 2010); the Skin Toxicity Assessment Tool (Berthelet et al., 2004); the Oncology Nursing Society (ONS)
Radiation Therapy Patient Care Record, using the CTCAE, version 2.0
(Catlin-Huth, Haas, & Pollock, 2002); and the
Radiation-Induced Skin Reaction Assessment Scale (Noble-Adams, 1999a, 1999b)
(see Table 2). Each assessment tool can be used to identify grades or ranges of skin
reactions from erythema to dry and moist
desquamation. Most of the tools are practitioner or observer assessments that
do not capture symptoms or impact of skin reactions. A skin assessment should
be completed at baseline, prior to initiation of treatment, and reassessments
should occur minimally at weekly treatment appointments. Assessment should
include evaluation of observed physical changes, as well as patient symptoms.
Issues to assess include changes in color, appearance of erythema,
patchy dry desquamation, patchy or confluent moist desquamation, drainage,
odor, possible infection, and sensations of dryness, pruritis,
or pain. The distress and impact associated with radiodermatitis
on quality of life, daily living, self-care ability, and financial impact of
caring for the skin reaction also are important areas of assessment.
Methods and Process
ONS’s Radiodermatitis Putting Evidence Into Practice (PEP) Team
comprised five advanced practice nurses and three staff nurses with expertise
in the field of radiation oncology. The team used the problem, intervention,
comparison, and outcome process for determining appropriate topics for the
literature search. The evidenced-based review of literature included clinical
practice guidelines, systematic reviews, and clinical research studies. Because
of the small number of research studies, the search was limited to studies done
within the past 10 years, rather than five years. Studies were limited to those
completed with human participants. All research was published in English.
Unpublished research (e.g., abstracts, theses) was excluded. The following
search engines were used: MEDLINE®, the National Library of
Medicine’s database, CINAHL®, CancerLit®,
and the Cochrane Database. The ONS Weight of Evidence Classification was used
in the review and categorization of each article (see Baney
et al., 2011).
The PEP team members reviewed materials via telephone or Web conferencing from
August 2009 through June 2010. Evidence tables, guideline tables, expert
opinion tables, and definition lists were developed for the radiodermatitis
PEP chapter (see Baney et al., 2011). Three external
radiation oncology experts, as selected by the ONS PEP project coordinator,
reviewed the content.
Recommended for Practice
Intensity-Modulated Radiation Therapy
Three
studies demonstrated reduced skin toxicity in patients with breast cancer
receiving IMRT versus conventional radiation therapy. In all studies, the
National Cancer Institute Cancer Therapy Evaluation Program’s (2010) CTCAE was
used to grade skin toxicity.
Freedman et al. (2009) compared 399 women treated with IMRT to 405 women
treated with conventional radiation for breast cancer. The IMRT group had
significantly less grade 2 or higher skin toxicity (p < 0.001) and
less time spent per week with grade 2 or 3 dermatitis (p < 0.001) as
compared to the conventional radiation group. Significant predictors (p <
0.02) of grade 2 or higher dermatitis were use of IMRT versus conventional
techniques in the administration of radiation therapy, large bra size,
treatment weeks 2–6, and receiving chemotherapy or tamoxifen
before or during radiation.
Pignol et al. (2008) studied skin reactions and pain
in women with early-stage breast cancer treated with IMRT (N = 170) versus
conventional therapy (N = 161). Fewer patients treated with IMRT experienced
moist desquamation during and up to six weeks postradiation
treatment as compared to those receiving conventional treatment (p = 0.002).
IMRT (p = 0.003) and smaller breast size (p = 0.001) were associated with
decreased risk of moist desquamation in a multivariate analysis. Consistent
with Freedman et al. (2009), breast size and use of technology predicted the
degree of skin reaction.
Freedman et al. (2006) compared 73 women receiving breast IMRT to 60 historical
controls treated with conventional radiation therapy. Grade 1 desquamation was
higher in the IMRT group (37% versus 10%). Grade 2 desquamation occurred in 21%
of IMRT recipients as compared to 38% of patients treated conventionally (p =
0.0001). Use of IMRT (p = 0.001) and breast size (p < 0.0001) were the only
significant predictors of moist desquamation (Freedman et al., 2006).
Although research regarding IMRT for breast radiation is promising for the
reduction of radiodermatitis, use of this
intervention in daily practice is not considered standard care for patients
with breast cancer. IMRT is not routinely covered by most insurance carriers in
the United States, except in the treatment of head and neck and prostate
cancers.
Usual Hygiene Practices
Washing: The practice of washing the skin and hair in the treatment field
along with the use of deodorant has created controversy in the clinical
setting. Preventing normal socially accepted hygiene practices distresses
patients (McQuestion, 2010; Roy, Fortin, & Larochelle, 2001). Three research studies demonstrated that
skin washing in the irradiated fields with mild soap and water or water alone
did not increase skin toxicity. An additional study compared normal skin care
practice to warm water only.
Roy et al. (2001) randomized 99 patients with breast cancer receiving radiation
to washing with mild soap and water or not washing the treatment field. Those
who washed had lower overall maximum skin toxicity scores (grade 2 or higher)
based on RTOG scoring criteria (p = 0.04). Moist desquamation was significantly
higher in the nonwashing group (p = 0.03) (Roy et
al., 2001).
In a study of 107 patients receiving cranial radiation, Westbury, Hines, Hawkes, Ashley, and Brada (2000)
compared usual patient scalp care practices to patients instructed not to wash
their hair during treatment. Based on RTOG scoring criteria, the severity of
skin reactions did not increase in the hair washing group (Westbury et al.,
2000).
Meegan and Haycocks (1997) demonstrated that patients
using their typical skin-care regimens did not have increased severity of skin
reactions during and after radiation therapy. In the study, 94 patients used
warm water only, excluding all lotion, soaps, and deodorants in the treatment
fields, compared to 64 patients with no restrictions on normal skin-care
practices. No significant differences were found in skin assessment scores
between the two groups; however, patient self-scoring of skin reaction severity
was consistently higher in patients using only warm water (Meegan
& Haycocks, 1997).
Campbell and Illingworth (1992) randomized 95 women treated with radiation for
breast cancer to not washing, washing with water alone, or washing with soap
and water in the treated area. Comparisons showed a statistically significant
reduction in itching and erythema (p < 0.05) with
washing (water alone and washing with soap) as compared to not washing. Women
who washed had markedly smaller desquamation scores than those not washing. The
findings supported allowing patients to wash (with water alone and soap) during
radiation therapy (Campbell & Illingworth, 1992).
Deodorant: Two studies addressed use of nonaluminum deodorant during
radiation. Concerns regarding deodorant focused on direct skin effects and
potential effects on the surface dose of radiation.
In a clinical study by Theberge, Harel,
and Dagnault (2009), 84 women with breast cancer
receiving radiation were randomly assigned to nonaluminum deodorant versus no
deodorant. Statistically significant findings favoring the use of deodorant
included a reduction in grade 2 axillary dermatitis
(p = 0.02), axillary moist desquamation (p = 0.003),
discomfort and pain to axillary region (p = 0.004 and
p = 0.002, respectively), self-reported axillary pruritis (p = 0.0002), grade 2 breast dermatitis (p =
0.05), and moderate to severe pain in the entire treatment area (p = 0.03)
compared to those who did not use deodorant (Theberge
et al., 2009).
In a nonclinical study, Burch, Parker, Vann, and Arazie
(1997) examined skin surface doses with 15 products, including deodorants,
powders, and creams, using an ionization chamber with large and small radiation
field sizes. Very little difference was found in surface doses among products
when comparing normal application thickness to five times the thickness. In
addition, no differences were found between metallic and nonmetallic products
(Burch et al., 1997).
Likely to Be Effective
Calendula
A large
randomized, controlled trial demonstrated the effectiveness of calendula
ointment compared to Biafine® topical
emollient for prevention of radiodermatitis.
Pommier et al. (2004) randomized 254 women with breast
cancer to twice daily (or more) application of calendula or Biafine
on irradiated fields. Patients applying calendula had a reduced prevalence of
grade 2 dermatitis (p < 0.001), lower reported levels of pain (p < 0.03),
and fewer treatment interruptions. Self-assessed prevalence of erythema and allergic reactions also were lower. Skin
toxicity of grade 2 or higher was significantly increased for women whose body
mass index was 25 or higher (p < 0.001) and for women who had received prior
chemotherapy (p = 0.01).
Hyaluronic Acid and Sodium Hyaluronate
The literature reviewed on hyaluronic acid cream
(Ialugen®) included a large double-blind,
randomized, placebo-controlled trial and expert opinion guidelines. Bernier et
al. (2008) recommended use of hyaluronic acid topical
cream in the management of grade 2 or 3 skin toxicity in the absence of
infection. Liguori, Guillemin, Pesce,
Mirimanoff, and Bernier (1997) randomly assigned 134
patients receiving radiation therapy for head and neck, breast, or pelvic
cancers to 0.2% hyaluronic acid cream or placebo
twice daily, applied to the treatment field. The placebo group demonstrated
significantly higher acute radiodermatitis scores (p
< 0.01). Patients and physicians judged improved treatment efficacy with hyaluronic acid. In the subgroup of patients with head and
neck cancer, a significant difference was observed in favor of hyaluronic acid following observation at week 3 (p =
0.0003), week 4 (p = 0.0001), and week 5 (p = 0.004) (Liguori
et al., 1997).
Benefits Balanced With Harms
No
literature was found in this category.
Effectiveness Not Established
Topical and
oral treatments, as well as various dressings, have been studied for effects on
radiation-induced skin toxicities. A systematic review by Kedge (2009) examined
results across 10 randomized, controlled trials from 1990–2008 with about 575
patients using topical agents and hydrocolloid dressings. No convincing
evidence was found for any intervention studied (Kedge, 2009). The Supportive
Care Guidelines Group of Cancer Care Ontario also concluded insufficient
evidence to support or refute a wide variety of topical, IV, and oral agents (Bolderson et al., 2005).
Topical Agents
Aloe vera: In a systematic review, Vogler and Ernst (1999) looked at 10 controlled clinical
trials involving 740 participants using aloe vera
orally or topically. They concluded that topical application of aloe vera did not appear to prevent radiation-induced skin
damage. However, firm conclusions could not be drawn from the review because of
multiple methodologic problems (e.g., small sample
size per study, variety of agents compared to aloe vera)
in the research (Vogler & Ernst, 1999).
Aloe vera was studied in four randomized, controlled
trials, two of which were blinded and conducted at multiple sites (Heggie et al., 2002; Williams et al., 1996). Study
populations included patients receiving radiation for any field where skin
reactions were expected to occur.
Merchant et al. (2007) compared aloe vera gel to an
anionic polar phospholipid (APP) cream in 45
pediatric patients receiving radiation to the thorax, axilla,
and craniocervical regions. Grouped common toxicity
criteria scores were favorable for use of APP cream as compared to aloe vera gel (p = 0.004). In comparing first and last
assessments, two dermatologic variables, dryness (p = 0.04) and peeling (p =
0.02), supported use of APP cream over aloe vera
(Merchant et al., 2007).
Heggie et al. (2002) performed a double-blind,
randomized controlled trial comparing topical aloe vera
gel to a water-based moisturizing cream in 208 women treated with radiation for
breast cancer. Aqueous cream was significantly more effective than aloe vera gel in reducing the incidence of dry desquamation (p
< 0.001) and moderate to severe pain (p = 0.03). Only nonchemotherapy
recipients using aloe vera showed a significantly
reduced incidence of moderate or higher erythema (p =
0.02).
Olsen et al. (2001) compared use of aloe and mild soap to mild soap alone in 70
patients receiving radiation to the head and neck, chest, and extremities.
Olsen et al. (2001) concluded that adding aloe seemed to have a protective
effect, but did not provide definitive data to support the conclusion.
Williams et al. (1996) reported results of two randomized, controlled trials.
One trial compared aloe vera gel to a placebo gel,
whereas the other compared aloe vera to no treatment.
Both studies included women receiving radiation for breast cancer (N = 194 and
N = 108, respectively). No significant differences were found between groups in
severity or prevalence of skin toxicities (Williams et al., 1996).
MAS065D: Two small trials assessed the effect of MAS065D (Xclair®) in managing radiodermatitis.
Leonardi et al. (2008) randomly assigned 35 women
with breast cancer receiving radiation to MAS065D or an emollient base cream
with similar color and consistency to MAS065D. Results demonstrated less
burning in the radiation field (p = 0.04), less desquamation (p = 0.02), and
lower maximum skin toxicity grade (p < 0.0001) in the MAS065D group (Leonardi et al., 2008).
Primavera et al. (2006) conducted a double-blind, vehicle-controlled study in
22 women with breast cancer receiving radiation. Comparisons were made between
MAS065D and a control topical agent being applied to two different sections of
skin within a patient’s radiation field. The mean erythema
score with MAS065D was found to be significantly lower than control at the
fifth treatment visit (p = 0.03). Patients and investigators preferred MAS065D
(p = 0.007 and p = 0.04, respectively).
Steroids: Four randomized, controlled studies were conducted to
determine the effectiveness of various topical steroids for the prevention or
management of radiodermatitis. All reviewed studies
had small sample sizes and methodologic issues,
including a variety of treatment delivery methods (i.e., different radiation
techniques or doses and concentrations of steroid), lack of randomization,
comparison to cohort groups, and investigator-developed assessment tools that
lacked proven validity and reliability. No study demonstrated a clear benefit
for use of topical steroids.
Omidvari et al. (2007) randomized 51 women recieving radiation for breast cancer to three arms: bethamethasone, petrolatum, and no treatment. Use of bethamethasone demonstrated no clear benefits (Omidvari et al., 2007).
Shukla, Gairola, Mohanti, and Rath (2006) randomly
assigned 60 women undergoing radiation therapy for breast cancer to the use of beclomethasone spray versus no intervention. Patients using
beclomethasone had less prevalence of axillary wet desquamation than the control group (p =
0.04). Whether differences in skin toxicity were associated with topical
treatment or method of radiation delivery was unclear (Shukla
et al., 2006).
Bostrom, Lindman, Swartling, Berne, and Bergh (2001) examined the use of mometasone furoate versus
emollient cream in 50 women treated with radiation for breast cancer. Erythema was calculated using spectrophotometry,
with a significantly lower maximal score reported for those treated with mometasone furoate (p = 0.01) (Bostrom et al., 2001).
Schmuth et al. (2002) randomly assigned women with
breast cancer receiving radiation to 1% methylprednisolone
aceponate cream (N = 10) or dexpanthenol
(N = 11). The experimental arms were compared to a historical cohort of 15
patients. Women treated in the steroid arms had fewer high-grade skin
reactions, but the finding was not statistically significant (Schmuth et al., 2002).
Dexpanthenol: In four clinical trials,
a specific steroid, dexpanthenol (Bepanthol®),
was compared to other treatments for management of radiodermatitis.
The study by Schmuth et al. (2002) was summarized in
the previous section. In two studies (Roper, Kaisig,
Auer, Mergen, & Molls, 2004; Schreck,
Paulsen, Bamberg, & Budach, 2002), dexpanthenol was the institutional standard of care and
used as the control arm. The fourth study (Lokkevik, Skovlund, Reitan, Hannisdal, & Tanum, 1996)
compared dexpanthenol to no topical treatment. All
four studies had small sample sizes.
Roper et al. (2004) compared dexpanthenol to theta
cream in a randomized, controlled study of 20 women receiving radiation
treatment for breast cancer. No differences were found between study groups,
and neither topical treatment demonstrated benefit (Roper et al., 2004).
Schreck et al. (2002) completed a quasiexperimental-design
study in 12 patients treated with radiation for head and neck cancer, applying dexpanthenol cream or azulon
powder at onset of dry desquamation. Azulon powder
was used on both sides of the neck from the start of treatment until onset of
dry desquamation, then used as control for comparison to dexpanthenol.
Because of the small sample size, no statistical analysis was completed.
Descriptive findings indicated no differences between treatments (Schreck et al., 2002).
Lokkevick et al. (1996) completed a quasiexperimental study in 79 patients treated for head and
neck or breast cancer receiving radiation therapy. Patients used dexpanthenol on one side of the treatment field, and no
topical treatment on the opposite side. No differences were found in erythema, moist desquamation, pruritis,
or pain (Lokkevik et al., 1996).
Glutathione and anthocyanin: One randomized,
placebo-controlled trial (Enomoto et al., 2005)
evaluated the effectiveness of RayGel®
(glutathione and anthocyanin) in 30 women given
radiation therapy for treatment of breast cancer. Women were randomized to
glutathione and anthocyanin versus a water-based gel.
Although some results appeared to favor glutathione and anthocyanin,
they were not statistically significant. In addition, all women were instructed
to use aloe vera and vitamin E, compromising findings
(Enomoto et al., 2005).
Sucralfate: Falkowski,
Trouillas, Duroux, Bonnetlanc, and Clavere (2011)
studied 21 women with breast cancer receiving radiation, using a quasiexperimental design. Different skin zones inside and
outside of the radiation treatment field were compared using spectrophotometry and RTOG scoring. No differences were found
between sucralfate-treated and nontreated
areas (Falkowski et al., 2011).
Wells et al. (2004) conducted a randomized, double-blind controlled trial in
357 patients with head and neck, breast, or anorectal
cancer receiving radiation therapy. Participants were randomized to one of six
treatment combinations using an aqueous cream, sucralfate
cream, or no cream. Within each group, further randomization occurred to either
a dry or hydrogel dressing. No differences were found
among groups in time to moist desquamation, severity of skin reaction, or
discomfort. The sucralfate cream group had lower erythema readings via spectrophotometry
than the aqueous cream group, but lowest readings were with the no cream group
(Wells et al., 2004).
Maiche, Isokangas, and Grohn (1994) completed a quasi-experimental study in 44
women undergoing radiation treatment for breast cancer. Patients applied sucralfate or a base cream to either side of the surgical
scar. The development of grade 1 or 2 skin reactions over the course of
treatment tended to occur later in the sucralfate
group. Recovery time of skin reaction was faster and the severity of grade was
lower in the sucralfate group postradiation
(p = 0.05) (Maiche et al., 1994).
Moisturizing cream: A prospective, randomized, three-arm controlled
trial compared the use of Lipiderm® to trolamine (Biafine) to no
prophylactic treatment for the prevention of radiodermatitis
in 74 women with breast cancer. The study did not refute or support either
product in terms of radioprotection (Fenig et al.,
2001).
Urea lotion: Momm, Weibenberger,
Bartelt, and Henke (2003) investigated whether moist
skin care with urea lotion (Eucerin®)
would reduce acute radiation skin toxicity in a study of 88 patients given
radiation for head and neck cancer. A 3% urea lotion was compared to
conventional dry skin care; results showed higher skin toxicities in patients
using the dry skin care protocol versus patients using the moist skin care
protocol with urea lotion (p < 0.05)
(Momm et al., 2003).
Anionic polar phospholipid cream: As discussed
previously, Merchant et al. (2007) tested APP cream versus aloe vera gel in 45 pediatric patients with various cancers.
Overall results suggested APP cream was more effective than aloe vera gel by grouped common toxicity scores (p = 0.004).
However, the sample size of 45 was small (Merchant et al., 2007).
Vitamin C: Halperin, Gaspar, George, Darr, and Pinnell (1993) studied
65 patients receiving cranial irradiation for metastatic disease. A 10%
ascorbic acid solution was applied to one side of the radiation field, and a
vehicle control solution was applied on the opposite side. No benefit was found
from use of ascorbic acid lotion (Halperin et al.,
1993).
Chamomile cream and almond ointment: Maiche, Grohn, & Maki-Hokkonen (1991)
compared the use of chamomile cream (Kamillosan®)
to almond ointment in 48 women receiving radiation treatments to the breast.
Participants served as their own control by applying chamomile cream or almond
ointment to randomly determined sections of their radiation field twice daily
during treatment. Overall, no significant differences were observed among use
of chamomile cream, almond ointment, or no topical treatment.
Sodium sucrose octasulfate: Evensen, Bjordal, Jacobsen, Lokkevik, and Tausjo (2001)
tested sodium sucrose octasulfate as prevention for
radiation-induced skin damage in 60 patients receiving radiation for head and
neck cancer. Patients served as their own controls by applying sodium sucrose octasulfate to one side of the neck and a placebo to the
opposite side. Mean skin reaction values were slightly higher on the placebo
side (p = 0.02) (Evensen et al., 2001).
Dressings
Hydrocolloid dressings: Evidence for use of hydrogel
and hydrocolloid dressings was mixed in a systematic review by Kedge (2009) of
randomized, controlled studies. The review observed patient comfort in some
studies, whereas others showed no differences. One study demonstrated increased
healing time with hydrogel dressings (MacMillan et
al., 2007).
Gollins, Gaffney, Slade, and Swindell
(2008) randomly assigned 30 patients with head and neck or breast cancer who
developed moist desquamation during radiation to receive hydrogel
dressings or gentian violet. The study showed a progressive reduction in moist
desquamation in the hydrogel group (p = 0.003) over
14 days. A difference was observed in median time to healing of 12 days in the hydrogel group as compared to 30 days in the gentian violet
group. The study was weakened by the withdrawal of 62% of patients in the
gentian violet group and a lack of a nontreatment arm
for definitive comparisons (Gollins et al., 2008).
The use of hydrogel in patients with moist
desquamation also was studied by MacMillan et al. (2007). Hydrogel
and nonadherent dressings were compared in 100
patients with head and neck, breast, or anorectal
cancer treated with radiation. Patients were randomly assigned to treatment of
moist desquamation at the start of radiation, beginning the assigned treatment
only when moist desquamation occurred. Skin reactions of patients assigned to hydrogel had a prolonged period of moist desquamation (p =
0.03). Because of the higher costs for hydrogel and
the lack of supportive evidence of superior action, hydrogel
was not recommended (MacMillan et al., 2007).
Mak et al. (2005) studied use of nonadherent
dressings versus gentian violet in 142 patients postradiation
with unhealed wounds. Participants were randomly assigned to dressing or
gentian violet. No significant differences were found between groups in
healing, healing time, sleep, mood, and restriction of neck movement (Mak et al., 2005).
In a trial by Mak, Molassiotis,
Wan, Lee, and Chan (2000), hydrocolloid dressings were examined for management
of moist desquamation postradiation. In the study, 39
patients with various radiation treatment areas who developed moist
desquamation were randomly assigned to receive gentian violet or hydrocolloid
dressings. No differences were found between groups for healing time or pain (Mak et al., 2000).
Silver leaf dressings: Two studies investigated the effectiveness of
silver leaf dressings, and both were limited by very small sample sizes. Vavassis, Gelinas, Chabot Tr, & Nguyen-Tan (2008) studied 12 patients treated
with radiation for head and neck cancer. Silver leaf dressings were applied to
one side of the neck and silver sulfadiazine was applied to the opposite side
for treatment of radiodermatitis. No difference was
found in improvement between the silver leaf dressing and the control groups.
However, the silver leaf dressing reduced severity of reaction among those with
the same dermatitis grade, accelerated healing, and improved pain control (Vavassis et al., 2008).
Vuong et al. (2004) compared 15 patients with anal or
gynecologic cancers receiving radiation using silver leaf dressing versus
historical controls using silver sulfadiazine at occurrence of symptomatic
dermatitis. All study participants used silver leaf dressings from day 1 of
radiation until two weeks after completion of treatment. The mean dermatitis
score among those using silver leaf was significantly lower than control (p
< 0.001). Vuong et al. (2004) concluded that
silver leaf dressing is effective in reducing radiodermatitis.
No-sting barrier film: Graham et al. (2004) compared the use of no-sting
barrier film (Cavilon®) versus glycerin
cream in relation to skin toxicity and rates of moist desquamation. The study
sample consisted of 58 women treated with radiation for breast cancer.
Participants applied control cream to one portion of the radiation field and
no-sting barrier to the alternate half of the field. In the presence of moist
desquamation, treatment was switched to a hydrocolloid dressing. No-sting
barrier was associated with a lower total skin toxicity score (p = 0.005) and
lower prevalence of pruritis (p = 0.01) (Graham et
al., 2004).
Granulocyte macrophage–colony-stimulating factor: Kouvaris,
Kouloulias, Plataniotis, Balafouta, and Vlahos (2001) examined the effectiveness of
GM-CSF–impregnated gauze in 61 women treated with radiation for vulvar cancer. All participants used steroid cream. When
the treatment group reached 20 Gy, they began using
GM-CSF–impregnated gauze. Patients treated with GM-CSF had overall lower pain
results (p = 0.001) and less severe skin toxicity (p = 0.008) as compared to
historical controls who used only steroids. However, the study had a small
sample size and lacked a prospective control group (Kouvaris
et al., 2001).
Honey-impregnated gauze: Robson and Cooper (2009) reported a small case
series with four patients in which honey was used as a primary dressing for
managing radiation skin toxicity with impaired healing. The use of honey for
chronic wound healing prompted this study in patients with radiation-induced
skin damage. In all cases, the change from conventional dressings to topical
application of honey was followed by anecdotal noticeable improvement in
healing (Robson & Cooper, 2009).
Oral Treatments
Zinc: Lin, Que, Lin, and Lin (2006) used zinc
supplements versus placebo capsules in a randomized, double-blind controlled
study of 97 patients with head and neck cancer receiving radiation. Grade 2 (p
= 0.14) and grade 3 (p = 0.009) dermatitis were less prevalent in those taking
zinc across all weeks of therapy. In patients receiving concurrent
chemotherapy, zinc did not show any benefit (Lin et al., 2006).
Red wine: Morganti et al. (2009) completed a
retrospective analysis of 348 women given radiation for breast cancer to
evaluate potential protective effects of red wine. The incidence of grade 2 or
higher acute skin toxicity was greater in patients without red wine intake (p =
0.002). In addition, the risk of high grades of skin toxicity in patients who
reported drinking one glass of red wine per day was lower than in nondrinkers
(p = 0.006) (Morganti et al., 2009).
Sucralfate: Lievens
et al. (1998) conducted a randomized, placebo-controlled double-blind study in
83 patients receiving radiation for head and neck cancer to determine whether
oral sucralfate could reduce acute radiation-induced
toxicities. However, Lievens et al. (1998) found no
evidence that sucralfate reduced side effects.
Proteolytic enzymes: Gujral et al. (2001) studied the use of oral proteolytic enzymes (papain, trypsin, and chymotrypsin) (Wobe-Mugos®) versus no oral intervention in the
prevention of acute radiation side effects. The prospective, randomized,
open-label trial examined 98 patients receiving radiation for head and neck
cancers. Maximum skin toxicity was significantly lower in the enzyme group (p
< 0.001). Based on the results, additional studies in larger, more
rigorously controlled trials would be beneficial (Gujral
et al., 2001).
Effectiveness Unlikely
Trolamine
Five
studies reported on the use of trolamine (Biafine) for the prevention and management of radiodermatitis. As discussed earlier, Pommier
et al. (2004) compared calendula to trolamine.
Patients treated with trolamine had less effective
results than those treated with calendula (Pommier et
al., 2004).
In a multicenter phase III trial, Elliott et al. (2006) compared trolamine with supportive care in 547 patients receiving
radiation for head and neck cancer. Participants were randomly assigned to
prophylactic trolamine, trolamine
as the specific intervention for dermatitis, or best supportive care (1 of 14
products) preferred and used by the individual institutions participating in
the trial. Results demonstrated no advantage for trolamine
or differences across groups in rates of grade 2 or higher radiodermatitis
(Elliott et al., 2006).
As discussed previously, Fenig et al. (2001)
conducted a randomized, prospective trial of 74 patients with breast cancer
receiving radiation. Patients were randomized to Biafine,
Lipiderm, or no treatment. The results showed no advantage
for either preparation compared to the nontreatment
arm (Fenig et al., 2001).
In an exploratory phase II intervention trial, Szumacher
et al. (2001) assessed the efficacy of Biafine in the
prevention of grade 2 acute radiodermatitis. Sixty
women treated with radiation for breast cancer were included in the trial. All
women received concomitant chemotherapy. Most women developed grade 2 radiodermatitis during the course of treatment; however, no
control group existed for comparing effects (Szumacher
et al., 2001).
Fisher et al. (2000) conducted a multicenter trial with 172 analyzable patients
with breast cancer receiving radiation. Biafine was
compared to best supportive care. The study showed no difference in maximum
skin toxicity or prevalence of grade 2 or higher skin toxicity between
treatment arms. In addition, no differences were found between the treatment
arms when reviewing prevention of, time to, or duration of radiodermatitis.
Biafine appeared to have a slight advantage in women
with larger bra cup size (Fisher et al., 2000).
Not Recommended for Practice
Gentian Violet
Gentian
violet was discussed as a control for prevention or management of radiodermatitis in several studies and a systematic review
(Gollins et al., 2008; Kedge, 2009; Mak et al., 2000, 2005). Despite its use in practice and as
a control in past trials, gentian violet is no longer recommended by the
Department of Health in the United Kingdom because of its carcinogenic
potential in animals (Kedge, 2009). The tissue-damaging potency of crystal
violet dyes was demonstrated in experimental models of rats and rabbits. In
addition, the tissue-irritating effect of gentian violet also has created
controversy regarding its use on radiation-induced moist wounds (Eriksson &
Mobacken, 1977; Mobacken
& Zederfeldt, 1973). In vitro, crystal violet was
cytotoxic at low concentrations to HeLa cells and fibroblasts (Norrby
& Mobacken, 1972). For those reasons, gentian
violet is not recommended for practice.
Expert Opinion
McQuestion (2010) and the Supportive Care Guidelines Group (Bolderson
et al., 2005) have provided clinical recommendations for general skin care for
patients receiving radiation therapy based on literature, systematic review,
and guidelines review (see Figure 1). In addition, Bernier et
al. (2008) included guidelines for care during radiation with concurrent
epidermal growth factor receptor inhibitors (see Figure 2).
Implications for Nursing Practice and
Research
The review
of the evidence indicates that ongoing research in prevention and management of
radiodermatitis is warranted. The literature
generally lacks support for products being used in practice today. Basic skin
care is rooted largely on anecdotal experiences, institutional and patient
preferences, and product availability. Wide variations and inconsistencies
exist between practitioners in the same institution or department because no
widely accepted standardized skin-care protocols exist. That results in conflicting
information being provided to patients and their families. The evidence to date
is insufficient to support any interventions, with the exceptions of IMRT and
basic skin care hygiene (e.g., washing the irradiated skin). Despite lack of
evidence, practitioners recognize the need to intervene, making radiodermatitis and its associated symptoms an area
warranting additional nursing research. Advanced practice oncology nurses have
a critical role, possessing the skills necessary to conduct research and
develop the evidence base for the prevention and management of radiodermatitis.
Future research should use larger sample sizes with varied patient populations
receiving radiotherapy to different treatment sites. More research also is
needed in diverse ethnic populations. Study endpoints should be clearly
defined: Is the goal to prevent, delay, or facilitate healing of radiodermatitis? Use of valid and reliable skin grading
scales and measurement tools should be consistent. The RTOG scale (Cox et al.,
2005) is used commonly in many radiation clinics. Unfortunately, reliability or validity data
has not been published, and the tool does not have the sensitivity to identify
practical clinical differences. Standardization with the timing of
interventions and assessment points should be identified clearly in the
research. In addition, consistency in assessment will allow for better
comparisons of interventions.
IMRT is the only treatment-related management strategy with sufficient evidence
for practice. Intervention studies in patients receiving IMRT are needed
because most research related to radiodermatitis has
been done in groups receiving therapy with older technologies. As radiation
treatment changes, studies of interventions aimed at the prevention or management
of radiodermatitis must be conducted to identify the
impact of newer technology. Treatment effectiveness trials also could include
symptom outcomes such as radiodermatitis, in addition
to focusing on the evaluation of products to prevent or manage this skin
reaction.
Interventions that have shown promise should be replicated in other cancer or
radiation treatment areas with larger sample sizes so the results can be
generalized more widely. The interventions currently showing the most potential
are calendula, hyaluronic acid, silver leaf nylon
dressings, and no-sting barrier films.
Conclusion
To date, no
gold standard exists for the prevention or management of radiodermatitis.
Attempted interventions to manage this significant side effect of radiation
therapy have been lacking in evidence. Future researchers should consider the pathophysiologic process of radiodermatitis.
Assessment tools require validation, incorporation of patient-reported
outcomes, and inclusion of patient experiences with associated symptoms
resulting from radiodermatitis (e.g., pain, pruritis).
Oncology nurses are crucial to the delivery of quality cancer care. Nurses
should be aware of the evidence-based interventions, or lack thereof, in the
management of radiodermatitis and use that
information to guide decision making in clinical practice. In their role as
educators, nurses must provide patients and families with information on
general skin care, when to expect skin reactions to occur, signs and symptoms
of infection, and the need to report those significant findings to their
healthcare team.
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Deborah Feight, RN, MSN,
AOCN®, CNS, is a manager and clinical nurse specialist at Northwest
Ohio Oncology Center/Toledo Radiation Oncology in Maumee, OH; Tara Baney, RN, MS, CRNP, ANP-BC, AOCN®, is an
oncology nurse practitioner at the Penn State Hershey Medical Group Oncology
Practice in State College, PA; Susan Bruce, RN, MSN, OCN®, CNS, is
an oncology clinical nurse specialist at Duke Raleigh Cancer Center in North
Carolina; and Maurene McQuestion,
RN, BScN, CON(C), MSc, is a
clinical nurse specialist at Princess Margaret Hospital in the University
Health Network in Toronto, Ontario, Canada. The authors take full
responsibility for the content of the article. The authors did not receive
honoraria for this work. The content of this article has been reviewed by
independent peer reviewers to ensure that it is balanced, objective, and free
from commercial bias. No financial relationships relevant to the content of
this article have been disclosed by the authors, planners, independent peer
reviewers, or editorial staff. Mention of specific products and opinions
related to those products do not indicate or imply endorsement by the Clinical
Journal of Oncology Nursing or the Oncology Nursing Society. (Submitted January
2011. Revision submitted April 2011. Accepted for publication May 7, 2011.)
Author Contact: Deborah Feight, RN, MSN, AOCN®, CNS, can be reached at dfeight@toledorad.org, with copy
to editor at CJONEditor@ons.org.
