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December 2014, Supplement to Volume 18, Number
6
Article
Evidence-Based Interventions for Cancer Treatment–Related Mucositis:
Putting Evidence Into Practice
June Eilers, PhD, APRN-CNS,
BC, Debra Harris, RN, MSN, OCN®,
Karen Henry, MSN, ARNP, FNP-BC, AOCNP®,
and Lee Ann Johnson, MSN, RN
Mucositis is an inflammatory process that can
involve the mucosal epithelial cells from the mouth
to the rectum. Historically, mucositis and stomatitis were used
interchangeably, but momentum has increased toward more specific terminology
since the 2000s. Stomatitis refers to inflammatory diseases of the mouth,
including the mucosa, dentition, periapices, and periodontium, whereas
mucositis refers more globally to an inflammatory process involving the mucous
membranes of the oral cavity and the gastrointestinal tract. In addition,
differentiation is needed regarding mucositis involving the oral cavity and the
remainder of the gastrointestinal tract that require use of a scope-type device
for close examination. As a result, oral cavity mucositis has been the focus of
the majority of the studies reported to date. The mucous membranes beyond the oral
cavity are more challenging to view, so the mouth has been presented as
revealing potential changes in the gastrointestinal tract. However, because of
the variation in morphology, function of different locations, and risks
associated with procedures to validate that speculation, evidence is limited.
The purpose of this article is to review evidence-based interventions for
mucositis, particularly in the oral cavity, and provide clinicians with
guidelines for nursing interventions.
Advances in the pharmacologic and supportive therapy
management of cancer treatment–related bone marrow suppression, nausea and
vomiting, and neutropenia-related infections have enabled dose escalation of
many treatment protocols. However, mucositis is now seen with increased frequency
and has evolved into a dose-limiting side effect of treatment. As a result,
prevention and management of this side effect have become more relevant for
cancer treatment success.
Once believed to involve a simple linear process,
mucositis is now seen as a complex process involving many different factors,
including the inflammatory process, cellular apoptosis, cytokines, cytotoxicity
of treatments, and micro-organisms in the oral cavity. Sonis (2004) developed a
proposed theoretical model to facilitate understanding of the complex process.
When the inflammation progresses to a breakdown in the protective mucosal
barrier, the micro-organisms normally present in the oral cavity and throughout
the gastrointestinal tract are able to enter the bloodstream and cause
potentially life-threatening infections that require strategic intervention. In
addition to the risk of infections, mucositis causes pain, restricts oral
intake, and contributes to malnutrition, interruption of treatment, and
increased hospitalizations. The incremental costs of mucositis are usually
associated with hospital stays, but the costs more than double when mucositis
is severe (Carlotto, Hogsett, Maiorini, Razulis, & Sonis, 2013).
Patients receiving chemotherapy, epidermal growth
factor receptor inhibitors, tyrosine kinase inhibitors, and/or radiation to the
head and neck are susceptible to the development of oral mucositis. Mucositis
occurs in about 40% of patients after standard doses of chemotherapy, and in as
many as 100% of patients receiving high-dose chemotherapy or combination
chemotherapy and radiation for head and neck cancer (Gibson et al., 2013).
Risks for mucositis include patient- and treatment-related factors (Barasch
& Peterson, 2003). Patient-focused factors include poor nutrition, age
(children and older adults), neutropenia, poor oral hygiene, genetic factors,
impaired salivary function, and use of alcohol and tobacco. Treatment-focused
risk factors include specific chemotherapy agents, chemotherapy dose and
administration schedule (high doses and stem cell transplantation), combination
radiation and chemotherapy, radiation for head and neck cancer, and concomitant
medications.
One of the reasons for the wide variation in
documented incidence of mucositis is inconsistent use of valid and reliable
instruments for the assessment of oral cavity changes. In addition, the
severity of mucositis can range from mild erythema to severe ulcerations and
bleeding. Visible changes associated with mucositis include erythema, ulceration,
and pseudomembrane formation. Patients with membrane changes experience varying
degrees of pain and changes in function including difficulty speaking and
swallowing. As a result, patients focus on the symptoms that affect quality of
life rather than the risk of life-threatening infection that is of concern to
healthcare professionals. The increased length of hospitalization and costs
attributed to mucositis are primarily related to pharmacologic management of
the infections associated with mucositis and altered ability to maintain oral
nutrition. To improve patient outcomes, the goals of nursing care are to
prevent membrane breakdown, maintain the ability to eat, and treat or prevent
pain.
This article builds on the earlier work by Oncology
Nursing Society (ONS) Putting Evidence Into Practice (PEP®)
mucositis teams (Eaton & Tipton, 2009; Harris, Eilers, Harriman,
Cashavelly, & Maxwell, 2008; Johnson, Henry, Saca-Hazboun, &
Samuel-Blalock, 2014). The span of the work attests to the commitment of
oncology nurses to make a difference in patient outcomes through evidence-based
practice and the ongoing challenge of mucositis in cancer care.
Methods
Search
Strategy
The literature search for relevant articles indexed
in PubMed and CINAHL® was conducted by a research librarian at ONS. Search terms
selected were consistent with prior searches for earlier PEP mucositis teams.
PubMed was searched for Mucositis[ti] OR
Mucositis[majr] OR “oral complication*” and CINAHL was searched
for (MM “Mucositis” OR MM “Stomatitis” OR TI Mucositis OR TI
stomatitis OR “oral complication*”) AND (cancer OR neoplasms
OR oncolog* OR chemotherap*). The articles had to include
patients with cancer and be published in English from May 1, 2008 to December
31, 2013. The search yielded 635 PubMed citations and 338 CINAHL citations. The
abstracts were reviewed based on the following inclusion criteria: (a) studies
were full research reports, systematic reviews, guidelines, or meta-analyses;
(b) studies had to report on the results of measurement of oral mucositis; (c)
studies examined an intervention aimed at affecting the problem of oral
mucositis; and (d) the study samples included patients with cancer. Studies
were excluded if they included grey literature, were descriptive, or reported
intervention effects on the pain of mucositis but not the actual incidence or
severity of the symptom mucositis itself. The screening of abstracts identified
138 articles for full article review. After removal of duplicates and studies
that did not meet inclusion criteria and the addition of manuscripts retrieved
in other topics meeting topic specific criteria, 100 publications were
identified for team member review. Four additional studies were identified
through an ongoing alert from the ONS research librarian. As a result, 104
publications were added to the prior ONS PEP mucositis work. Because the
methods used for the PEP reviews presented in this supplement were consistent
across the evidence-based practice teams, the detail of that content is available
in Johnson (2014).
Evidence
New research in mucositis is plentiful, particularly
related to novel agents with many derived from natural sources. The bulk of
those agents are classified as effectiveness not established because of
inadequate research, study design flaws, and conflicting or unconfirmed
results. The evidence was challenging to categorize because clinical
measurement of mucositis was inconsistent across trials and the validity and
reliability of the measurement was not always addressed by the study authors.
Recommended for practice:
This category includes interventions for which effectiveness has been
demonstrated by strong evidence from rigorously designed studies,
meta-analyses, or systematic reviews and for which expectation of harm is small
compared with the benefits. In previous reviews, only
oral care protocols were recommended. However, additional therapies now
included in this category are cryotherapy, low-level laser therapy, oral care
protocols, palifermin, and sodium bicarbonate mouth rinses (see Table 1).
Likely
to be effective: These interventions include evidence from a
single rigorously conducted controlled trial, consistent evidence from
well-designed controlled trials using small samples, evidence from
meta-analyses or systematic reviews using small samples, or evidence from
guidelines developed from evidence and supported by expert opinion. New
recommendations in this category include prophylactic chlorhexidine,
benzydamine, and lactobacillus lozenges (see Table 2).
Effectiveness
not established: This category includes interventions for
which data are insufficient or lack adequate quality. Numerous topical and
systemic pharmacologic and nonpharmacologic interventions have been studied for
efficacy in the prevention and management of oral mucositis or management of
associated pain. Evidence for the interventions is limited because of
inconsistent research results, small studies, and study designs. As a result, this
category includes the greatest number of agents (see Table 3 page 1 and page 2).
Effectiveness
unlikely: These are interventions for which lack of
effectiveness has been demonstrated by negative evidence from a single
rigorously conducted controlled trial, consistent negative evidence from
well-designed controlled trials using small samples, small samples within
meta-analysis or systematic reviews, or ineffective guidelines developed by
consensus or expert opinion. Three agents are in this classification. One of
these agents, Traumeel S, consists of multiple homeopathic substances that are
expected to have effects on wound healing and inflammation. This compound was
studied for its effect on oral mucositis. Other agents previously included and
remaining in this category are iseganan and Wobe-Mugos E. Studies with the
agents failed to produce statistically significant results (see Table 4). Misoprostol, an agent previously classified
in this category, has been moved to effectiveness not established.
Not recommended for practice: Interventions
in this category are those for which lack of effectiveness or harmfulness has
been demonstrated by strong evidence from rigorously conducted studies,
meta-analyses, or systematic reviews or interventions for which the costs,
burdens, or harms associated with the intervention exceed anticipated benefit.
Two agents remain in this category: chlorhexidine (nonprophylactic) and
sucralfate. The concerns with both agents for treatment of
mucositis is related to rinse-induced discomfort and taste. The
recommendation is supported by other systematic reviews (Kwong, 2004; Shih,
Miaskowski, Dodd, Stotts, & MacPhail, 2002; von Bültzingslöwen et al., 2006) (see Table 5).
Other
Agents
The extensive volume of literature available
regarding treatment and prevention of mucositis presents a challenge for
systemic reviews of evidence. In addition to interventions categorized for this
article, many others have been trialed and reported in various journals and
venues. When systematic reviews are included in a process such as is reported
here, multiple agents may have been involved. For the most part, the agents are
not included if the researchers concluded that they were not able to make a
recommendation. The numerous nonpharmacologic agents used in different settings
throughout the world also present a challenge because reviewers were not always
able to ascertain the details of the mixtures used. In addition,
nonpharmacologic interventions have not always received the same scrutiny prior
to use.
Agents that provide a protective barrier are an
example of another type of intervention (e.g., Episil®,
Gelclair, MuGard™). Typically, that type of agent is
regarded as a device, which undergoes a different review process prior to
approval for use. As a result, the studies reported may not have the same
scientific rigor required for randomized clinical trials. In addition, the
literature is not always clear regarding whether the primary outcome for a
given study is pain management or mucositis management.
Implications for Practice
This comprehensive review of mucositis literature
examined pharmacologic and nonpharmacologic interventions. Although only a
limited number of interventions met the criteria for recommended for practice,
they can provide clinicians with a basis for improved outcomes. Nurses are
frequently acknowledged as the professionals spending the greatest amount of
time with patients. The reality is that nurses in the clinical setting are
facing an ever-increasing number of challenges and are expected to do more with
less; therefore, nursing interventions such as basic oral care once seen as
routine in acute care settings are becoming much less routine.
That change in practice and the shift of the majority of cancer care to the
outpatient setting have contributed to inconsistency in the promotion of oral
care protocols that may be seen as too basic. This review adds support to the
use of oral care protocols as the foundation for mucositis prevention and
treatment. Nurses have a primary role to relay that importance to patients and
families and to provide instruction regarding agents to avoid, particularly those
containing alcohol, which has long been stated in the literature. In addition,
nurses should recommend the use of sodium bicarbonate mouth rinses as an
essential component of the routine oral care protocol.
Although indications for cryotherapy are restricted
to potentially mucotoxic agents with a short half-life being administered over
a relatively short time period, the intervention is low cost and evidence-based
nursing practice. Individuals with cancerous lesions in their oral cavity would
not be candidates for the intervention because the vasoconstriction induced by
the cooling has the potential to limit exposure of the cancer cells to
effective antineoplastic doses. In addition, cryotherapy is not indicated for
individuals receiving oxaliplatin because of problems with exposure to cold,
including pain, sensitivity, chest tightness, and laryngospasm.
The two remaining recommended interventions fall
within interprofessional care. Low-level laser therapy requires the necessary
equipment and trained personnel, so it is not available in all treatment
centers. Variations in terminology and dose related to the use of lasers and
other forms of light therapy for mucositis must be considered. The second
intervention, palifermin, has been approved by the U.S. Food and Drug
Administration for patients with hematologic malignancies who receive high
doses of chemotherapy and radiation therapy followed by stem cell rescue.
Palifermin requires a prescription, and, because of its expense, has not been
universally adopted. As a result, further work is needed to identify those to
treat with palifermin.
Nurses regularly involved in direct patient care
have difficulty staying adequately abreast of the literature on a topic such as
mucositis, particularly when their practice is not restricted to the management
of one symptom. Therefore, ongoing reviews are at the core to advancing
evidence-based practice. Nurses would benefit from ready availability of a
simplified version of the tables in the current article to guide practice.
With current advances in technology, this could be available electronically and
updated regularly. Such a table would also facilitate knowledge regarding the
current status of agents that have been identified as unlikely to be effective
and/or not recommended for practice. At this time, the number of agents in the
categories remains limited, which would facilitate easy review.
Knowledge of resources for accessing the available
reports of evidence summaries and how to evaluate new publications will assist
nurses in remaining up-to-date regarding changes in the literature.
Participation in professional organizations such as ONS and the Multinational
Association of Supportive Care in Cancer (MASCC) also provides nurses with
support to improve patient outcomes. Initial review of the recommendations from
these two organizations may trigger questions regarding inconsistencies. The
important component to consider when comparing any other guidelines is to be
aware of the criteria used when evaluating individual references and for
classification of the levels of evidence once the review content is
synthesized. Some of the difference is because ONS is focused on nursing and
primarily addresses care in North America, whereas MASCC is multinational and
more multidisciplinary in approach. That further explains the stronger focus on
dental interventions in the MASCC guidelines as compared to ONS clinical teams,
which do not incorporate dental services.
Nurses can contribute to the evidence guiding future
practice by participating in research studies. When the resources and
opportunities to participate are not available, nurses still can play a key
role in improving patient outcomes through performance improvement activities
at the local level or perhaps with other institutions. Participation will
necessitate the use of valid and reliable assessment tools.
Assessment is the essential initial step for nurses
to truly make a difference. Unfortunately, this process is inconsistent at best
and often uses instruments that lack essential validity and reliability (see
Harris et al., 2008). The more common assessment instruments, such as the
Common Terminology Criteria for Adverse Events, version 4.0 (U.S. Department of
Health and Human Services, 2010), and the World Health Organization’s (1979)
scale, focus on grading mucositis and are used in clinical trials, whereas some
instruments, such as the Oral Mucositis Assessment Scale (Sonis et al., 1999),
focus on mucous membranes with quantifiable function and objective or subjective
measures, and other instruments, such as the Oral Assessment Guide (Eilers,
Berger, & Petersen, 1988), address overall changes in the oral cavity but
do not grade the mucositis. Awareness of the divergent basis has implications
for nursing. Although pain is a common component of the mucositis experience,
retaining the pain assessment as a separate element is rational because the
rating is dependent on adequacy of treatment, not just the severity of
mucositis. Regardless of the mucositis assessment method chosen, the critical
aspect involved is that all healthcare providers in an institution should be
trained to rate the characteristics in a similar manner and cross-checked to
ensure accuracy between assessors.
A baseline assessment is needed to focus on risk
factors and the initial status of the oral cavity. Given that one of the
identified risk factors for mucositis is cancer treatment, increased
understanding is needed about the severity of the risk with a given treatment.
Knowing the emetogenecity of cancer treatments, including combination
protocols, guides treatment plans, but practice would also benefit from
increased awareness of the mucotoxicity of therapies. That information could
then enable nursing to establish electronic flags to accompany cancer treatment
order sets. The flags could include the need to conduct assessments, which
would be followed by evidence-based interventions. Such practice is dependent
on adequate evidence that tends to be available, but that will need to be
updated regularly.
As is commonly seen in research reports and reviews
of evidence, research on mucositis remains limited. The bulk of the literature
consists of small studies, nonrandomized designs, and a lack of valid and
reliable instruments. Another concern is lack of clarity if the intent of the
intervention was prevention or treatment of mucositis. Each concern needs to be
addressed with a higher level of science in future work. Although not included
in the results section of this review, the population treated and details of
the intervention protocol are important to note. Readers are encouraged to
refer to the original studies to determine the level of detail available for
the studies reported in the current article.
Future Recommendations
The work reported has strengths, particularly in the
volume reviewed and the number of nurses involved in the ONS PEP review for
mucositis. However, improvement is needed. Evidence-based practice encourages
nurses to evaluate their processes, which can also guide the PEP process. How
can nurses build on past reviews and continue to refine the process used? How
should nurses decide when to include miscellaneous agents individually to allow
building on the information with future work? How do nurses decide when an
intervention that was not found to have adequate evidence should move into an
archive rather than remain on an evidence table with an outdated reference?
Clinicians need to become critical consumers of attempts to promote the use of
specific interventions or new products. Requiring a review of the evidence
would serve clinicians and patients. As quality-improvement advocates,
clinicians have a responsibility to identify areas of concern and question why
established evidence is not being followed. In addition, researchers need to
create well-designed studies with valid and reliable instruments, a clear
purpose, intervention rigor, and an adequate sample. Finally, those results
must be published and shared to pursue excellence as a profession.
Conclusion
Mucositis is a complex process involving the mucosal
membranes of the oral cavity. Further knowledge regarding the process will
continue to drive the identification of new potential treatments and the
reevaluation of others. This update of the evidence for the prevention and
management of mucositis provides essential information to guide nursing care of
individuals experiencing this potentially life-threatening side effect. The
guidelines are not intended to be static in nature, and they should not be
blindly followed for every patient. Evidence-based practice must be seen as a
process requiring ongoing diligence and review of the literature as well as the
appropriateness for application with specific patients. Evidence-based
interventions are critical for optimal prevention and management of mucositis.
Similarly, the process used for PEP should continually be refined to allow for
the provision of meaningful information to clinicians.
Implications for Practice
Ø
Assess for oral mucositis with a valid and
reliable instrument as an initial step for prevention and management.
Ø
Develop evidence-based oral care protocols as
the foundation for cancer-related mucositis care.
Ø
Teach oral cavity self-management techniques
for mucositis to patients and family members.
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June
Eilers, PhD, APRN-CNS, BC, is a research associate professor in the College of
Nursing at the University of Nebraska Medical Center College of Nursing in
Omaha; Debra Harris, RN, MSN, OCN®, is a nurse manager at Oregon Health and Science
University in Portland; Karen Henry, MSN, ARNP, FNP-BC, AOCNP®, is a nurse practitioner
at the University of Miami Sylvester Comprehensive Cancer Center in Florida;
and Lee Ann Johnson, MSN, RN, is a research associate at the Oncology Nursing
Society in Pittsburgh, PA. 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. Eilers can be reached at june.eilers@unmc.edu, with copy to
editor at CJONEditor@ons.org. (Submitted May 2014. Revision submitted July 2014. Accepted for publication July 25, 2014.)
Key words: mucositis; oral cavity; nursing
management; evidence-based practice; cancer-related treatment
http://dx.doi.org/10.1188/14.CJON.S3.80-96
