To evaluate the timing of pegfilgrastim administration

Data from two large claim systems repositories obtained from 2003 to 2011 were pooled for analysis. Patients included were adults receiving at least one course of chemotherapy for a solid tumor or non-Hodgkin lymphoma. Patients were identified as receiving intermediate or high-risk regimens, and pegfilgrastim use was determined using Healthcare Common Procedure Coding System (HCPCS) codes on claims with service dates up to three days after the last chemotherapy administration of a cycle. Patients were grouped based on whether pegfilgrastim was given on the same day as the last chemotherapy dose or on days 2–4 after chemotherapy. Chemotherapy cycles that used different colony-stimulating factors (CSFs) were excluded from the analysis. The analysis was done for all cases in the first cycle and for all febrile neutropenia (FN) episodes.

• N = 45, 592 patients–179, 152 chemotherapy cycles   
• MEAN AGE = 55 years
• MALES: 10.9%, FEMALES: 89.1%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Seventy-eight percent had metastatic breast cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: Nine percent had cardiovascular comorbidities, and 11% had diabetes.

• SITE: Multi-site   
• SETTING TYPE: Other    
• LOCATION: United States

• PHASE OF CARE: Active antitumor treatment

• Retrospective cohort comparison

• FN episodes requiring inpatient care were determined based on admissions with a diagnosis of neutropenia, fever, or infection.
• FN episodes in the outpatient setting were identified by any ambulatory encounter with a diagnosis of neutropenia, fever, or infection and a HCPCS code on the same day for the IV administration of an antibiotic. 
• A narrower definition including only diagnoses of neutropenia and antibiotic administration was also evaluated.

The study was shown to be sufficiently powered. Overall, FN occurred in 3.9% of those receiving same-day prophylaxis in the first cycle compared to 2.8% of those receiving pegfilgrastim on days 2–4 after chemotherapy (p < 0.001). Across all cycles, FN occurred in 2.5% of the same-day patients versus 1.9% of the prophylaxis patients on days 2–4 (p < 0.001). Overall, pegfilgrastim was given on the same day as the last chemotherapy dose in 12% of the cases.

The findings suggest that the timing of pegfilgrastim administration does matter, and that administration according to prescribing information is more effective than administration on the last day of the chemotherapy cycle.

• Risk of bias (no random assignment)
• Measurement validity/reliability questionable
• Reliance on claims data is known to be prone to errors
• The definition of FN is somewhat questionable, as no specific diagnosis code exists for FN. The use of the combination of documented fever, use of antibiotics, etc., may not accurately represent clinical FN.

The findings suggest that the administration of pegfilgrastim according to the timing outlined in prescription information is more effective than administration on the last day of the chemotherapy cycle. While an additional patient visit for this injection may not be convenient, it is worth the reduction in risk for FN and attendant infectious complications. The findings point to the need for the development of practical alternatives to facilitate adherence to essential schedules, such as simple devices for patients to self-administer CSFs as needed, as is done with medications like insulin.

To assess the psychosocial impact of rapid genetic testing and counseling among women with newly diagnosed breast cancer

Patients were randomly assigned to rapid genetic counseling and testing (RGTC) or usual care control groups. Those in the RGTC group were offered an appointment with a clinical geneticist within five working days, and rapid DNA testing with results were provided within about four weeks. Participants complete study measures at baseline, and at 6- and 12-month follow-ups.

• N = 240  
• MEAN AGE: 44.85 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Most were in stage I or stage II breast cancer. About 10% had a prior history of breast cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: About 50% had at least come college education.

• SITE: Multi-site  
• SETTING TYPE: Not specified    
• LOCATION: Netherlands

PHASE OF CARE: Diagnostic

• Randomized, controlled trial

• Cancer-Worries Scale
• Decisional Conflict Scale (DCS)
• European Organization for Research and Treatment of Cancer Cancer Quality of Life Core 30 (EORTC QLQ-C30)
• EORTC QLQ-BR-2
• Hospital Anxiety and Depression Scale (HADS)
• Satisfaction with decision scale (SWD)

Ninety-six percent of those in the experimental group had genetic counseling consultation, and 33% had DNA testing prior to surgery. In the usual care group, 71% had genetic counseling and 62% had DNA testing, 10% prior to surgery. There were no differences between groups in worries, anxiety, depression, quality of life (QOL), decisional conflict, or satisfaction with decision-making. In both groups, worries and measures of psychosocial distress declined over time.

• Risk of bias (no blinding)
• Other interventions that might impact anxiety and distress were not identified.  
• Participants were highly educated and may not be reflective of the range of newly diagnosed patients .
• A high proportion of those in the control group had genetic counseling and DNA testing, so the control group was not that different in terms of care provided.

Findings did not show that offering rapid genetic counseling and testing had any effect on QOL, anxiety, or depression among individuals newly diagnosed with breast cancer.

To establish whether standard scalp care, as usually practiced by the patient, affects severity and course of acute skin radiation side effects, and to what extent advice on changing normal routine of hygiene causes distress

Patients receiving cranial radiation therapy were randomized to two groups. Group 1 patients were advised to continue normal scalp care. Group 2 patients were advised to avoid washing the irradiated area. Hair washing was not prohibited, but patients were advised to avoid it. Patients were assessed weekly over 10 weeks from the start of treatment, with recording of symptoms by patients and clinical assessment by an observer.

• The study sample was comprised of 59 male and 48 female patients (N = 107) who were randomized to group 1 (normal scalp care [n = 55]) or group 2 (no washing [n = 52]).
• Median age was 52 years in group 1 and 48 years in group 2.
• All patients had primary brain tumors or were receiving prophylactic cranial irradiation
• Patients received high (more than 30 Gy [n = 23]) or low-dose (less than 30 Gy [n = 84]) radiation therapy.

The study took place at The Royal Marsden NHS Trust in London, England.

The study used a randomized controlled trial design.

• Pain and itching were recorded by patients using a modified RTOG/EORTC acute skin reaction scoring on a scale of 0–3.
• Skin reaction was assessed using RTOG/EORTC scale for erythema/desquamation, on a scale of 0–4.
• Frequency of hair washing and distress of changing practice of normal hygiene were recorded on a self-completed diary card.
• Degree of distress was assessed on a four-point scale by group 2.
• Differences between area under the curve of male and female patients were assessed by t-test.
• Use of topical applications for treatment of skin reactions was recorded.
• Mann-Whitney Test was used to investigate differences between treatment groups at each time points.

No differences were reported between scores of skin reaction in the two groups. Itching was the main local symptom experienced by both groups, with no significant differences. A marginal difference occurred between patient groups at six weeks, with the patients in group 2 having more severe symptoms.

The practice of normal hair washing is not associated with increased severity of adverse skin reaction caused by megavoltage cranial radiation therapy. The time course of skin reaction was also not affected by the different practice of hair washing. Mild-to-moderate skin reaction is not exacerbated in patients continuing their usually regimen of hair care.

• After six weeks, completion of skin reaction assessments declined, and interpretation of results became more difficult.
• Patients did not stop hair washing completely and, therefore, the study assessed acute skin reaction for different hair-washing frequencies.
• The small trial size meant that statistical power of results was limited, particularly when stratifying by dose of radiation therapy.
• There is no discussion of validity and reliability symptom scoring used.
• Patients were not instructed to use any creams or lotions unless prescribed by their physician.

To compare the effect of single-day ondansetron use versus palonosetron in combination with aprepitant and dexamethasone

Patients were stratified into cisplatin and noncisplatin chemotherapy groups and then randomized. On day 1 prior to highly emetogenic chemotherapy (HEC), patients in group 1 received palonosetron at 0.25 mg IV. Group 2 received ondansetron at 24 mg orally 30 minutes before chemotherapy. Both groups received oral aprepitant at 125 mg on day 1 (60 minutes prior to chemotherapy) then 80 mg on days 2 and 3, and oral dexamethasone at 12 mg on day 1 then 8 mg on days 2, 3, and 4. Data were recorded on days 1–6 following chemotherapy administration.

• N = 40 (20 in each arm)  
• AVERAGE AGE = 52.9 years (ondansetron), 50.9 years (palonosetron)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Confirming breast cancer; one patient with lymphoma
• OTHER KEY SAMPLE CHARACTERISTICS: Chemotherapy-naïve or treated with low-emetogenic chemotherapy in the past; receiving first cycle of HEC (doxorubicin pr cyclophosphamide); day 1 of multi-day chemotherapy; patients had Eastern Cooperative Group performance statuses of grades 0–2 and were capable of taking oral medications; did not have an event of vomiting or retching within 24 hours before administration of the study medications; did not receive an antiemetic within 24 hours before study medication administration excluding the use of benzodiazepines; did not experienced grade 2 nausea or greater according to the Common Terminology Criteria for Adverse Events within 24 hours before chemotherapy administration; did not receive strong CYP450 3A4 inducers and/or inhibitors known to cause clinically relevant drug interactions within the week prior to study treatment and continuing through day 5; alanine aminotransferase and/or aspartate aminotransferase < 2.5 times upper limit of normal or total bilirubin < 1.5 times upper limit of normal; no known hypersensitivity to ondansetron, palonosetron, aprepitant, or dexamethasone

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University

• PHASE OF CARE: Active antitumor treatment

Prospective, open-label, randomized pilot study

• Patients used a diary.
• Patients were instructed to document the day and time of vomiting, retching, nausea, and rescue antiemetics use in real time. They also were instructed to rate their nausea based on the Common Terminology Criteria for Adverse Events (CTCAE) at the end of each day.
• Follow-up phone calls were made by the investigator to assess medication and diary adherence (day 2 or 3 to capture the acute time period and day 4, 5, or 6 to capture the delayed time period).

Thirteen patients (65%) in the palonosetron arm and eight patients (40%) in the ondansetron arm achieved an overall complete response (CR). In the acute setting, 11 patients (55%) in the ondansetron group and 15 (75%) in the palonosetron group achieved a CR. In the delayed setting, nine patients (45%) in the ondansetron group and 13 (65%) in the palonosetron group achieved a CR. In the ondansetron group, 11 patients reported the use of rescue antiemetics, and in the palonosetron group, seven patients reported antiemetic use (in both acute and delayed time periods). Few patients experienced episodes of retching or vomiting. Seven patients in the ondansetron group and eight in the palonosetron group reported acute nausea. Delayed nausea was reported by 11 patients in the ondansetron group and 12 in palonosetron group.

This pilot study demonstrated a consistently higher rates of CR and lower rates of vomiting and retching in the palonosetron group although there was no statistically significant difference.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Findings not generalizable
• Other limitations/explanation: No stratification of age (younger adults tend to develop more severe chemotherpy-induced nausea and vomiting than older adults)

Take caution before interpreting the results of this study because it did not use the most robust research design (i.e., randomization, blinding, placebo-control) to detect the drug's efficacy. This study highlighted the need to conduct a large, adequately powered study.

To evaluate the impact of a home-based walking program on patient symptoms of fatigue, sleep disturbances, and mood.

Patients were randomly assigned to the walking program or a usual care control group. The exercise intervention included a walking prescription based on the American College of Sports Medicine guidelines. The targeted exercise prescription included a brisk 20- to 30-minute walk with five-minute warm-ups and cool-downs five days per week. Exercise participants wore pedometers. Usual care patients wore pedometers during the first two weeks only. Throughout the study, patients in both groups received telephone contact on a biweekly basis to discuss physical activity and any concerns. For those in the exercise program, adjustments to the program were made, barriers to walking were discussed, and strategies for resolution were planned.

• One hundred twenty-six patients (61.1% male, 38.9% female) were included.  
• Mean age was 60.2 years (range 28–80).
• Patients had multiple solid tumor types; the most common were prostate, breast, and colorectal tumors.
• All patients were scheduled to receive chemotherapy or radiation therapy.
• Of the patients, 78.6% were Caucasian and 84.9% were married or partnered.

• Single site 
• Home 
• New Jersey

Patients were undergoing the active antitumor treatment phase of care.

This was a randomized, controlled trial.

• Piper Fatigue Scale (PFS)
• Profile of Mood States (POMS)
• Cooper Aerobics Center Longitudinal Study
• Physical Activity Questionnaire (PAQ) for exercise dose
• Pedometer
• Pittsburgh Sleep Quality Index (PSQI)
• Daily exercise and symptom log

Analysis of dropouts showed that significantly more ethnic minorities and those with lower educational levels withdrew (p < 0.03). There were no differences at the end of the study in sleep quality. There were no differences between groups in overall mean emotional distress scores; however, dose-response analysis showed that those who exercised more had less emotional distress (p = 0.03). There were no between-group differences in fatigue; however, analysis showed that those who exercised more had lower fatigue scores (p = 0.03). Subgroup analysis among patients with prostate cancer showed that exercise group members had better sleep quality (p < 0.001), less emotional distress (p = 0.048), and less fatigue (p = 0.009). PAQ findings were moderately correlated with pedometer results, suggesting that the PAQ may be a reasonable measure of exercise dose (Spearman = 0.37; p = 0.002).
 

Findings suggested that a home-based exercise program can be beneficial in patients receiving cancer treatment to reduce fatigue. Among patients with prostate cancer, the program resulted in improved sleep quality and less emotional distress and fatigue.

• The study had a risk of bias due to no blinding.
• Patient withdrawals were 10% or greater.

A home-based walking program is a simple intervention that can be beneficial to patients, and study findings showed that patients who exercised more had less fatigue and improved mood. In patients other than patients with prostate cancer, it did not appear that exercise improved sleep quality. This study included biweekly telephone follow-ups. Other studies have not shown the same level of results with home-based walking, suggesting that the follow-up component is probably important to maintain patient exercise program use. Of interest, patients who were less educated and of ethnic minorities were more likely to drop out of the study. This suggests that these groups of patients need to be examined more in order to see what interventions will be most likely to appeal to them.

To study the effects of psychosocial telephone counseling on anxiety, quality-of-life domains, and biomarkers

Eligible patients were randomly assigned to the telephonic intervention or usual care. Those receiving the intervention received a five-minute pre-call to reintroduce the purpose of the intervention and schedule initial sessions. Patients received four sessions of 20-60 minutes for education and counseling for problem solving, social support, communication skill development, and problem identification based on the transactional model of stress and coping. Follow-up letters with session summary and suggested homework assignments were mailed after each session. Surveys were mailed to participants for completion at baseline, 4 months, and 9 months.

• N = 168 at 4 months, 151 at 9 months  
• MEAN AGE = 44.75 years
• FEMALES: 00%
• KEY DISEASE CHARACTERISTICS: All had cervical cancer
• OTHER KEY SAMPLE CHARACTERISTICS: More than half had some college education. About 40% were Hispanic.

• SITE: Single site  
• SETTING TYPE: Home  
• LOCATION: California

• PHASE OF CARE: Late effects and survivorship

Randomized, controlled trial

• PROMIS depression short form
• Brief Symptom Inventory (BSI)
• Gynecologic Problems Checklist
• FACT (cervical and general questionnaires)
• Plasma cytokine measurement

Patients assigned to the intervention had significantly better scores for depression (p = 0.041) and cancer-specific concerns at four months (p < 0.05). There was no difference between groups in anxiety at four months. Patients assigned to the intervention demonstrated continued improvement in gynecologic problems at nine months. At nine months, there was no difference between groups in depression or anxiety.

Longitudinal evaluation of a telephonic psychoeducational intervention among survivors of cervical cancer showed benefit for depression and gynecologic problems in the first four months after the intervention. These differences were not maintained over the longer term.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Participant withdrawals of 10% or greater

Telephone-delivered psychoeducational intervention was associated with reduced depression and cancer concerns within the first few months of the intervention; however, these benefits did not appear to be maintained over the longer term. It is possible that there is a need for continued intervention in order to benefit patients in the longer term. Findings suggest that a telephone intervention delivery can be effective, and may be a practical way to be able to deliver this type of intervention, particularly for patients in rural areas, or those otherwise unable to travel to healthcare facilities.

To determine whether the consumption of fresh baker’s yeast (FBY) reduces constipation in opioid-treated patients with advanced cancer.

FBY is a fungus most commonly used in the kitchen for raising dough. In Argentina, FBY is available in a paste form that can be mixed with liquids and meals. It is used as both a food supplement to provide vitamins, and a bowel regulator. 

Patients initiated opioid therapy and concurrently received a daily dose of FBY in the morning for 15 days. FBY was dissolved in water at room temperature, with the option of mixing it with the patient’s favorite food. The initial dose was 6 g once a day in the morning. If patients did not have a bowel movement (BM), the dose was doubled daily until laxation occurred. The maximum dose was 50 mg. If no BM occurred within three days, a stimulant laxative was added to the treatment.  If no BM occurred within an additional two days, an enema was ordered. Results were assessed daily by phone.

• The study reported on a sample of 17 patients (9 men and 8 women).
• Median patient age was 59 years.
• Eastern Cooperative Oncology Group (ECOG) Performance Status was as follows: 1 (n = 4), 2 (n = 6), 3 (n = 4), and 4 (n = 3).
• Tumor sites were lung (n = 6), breast (n = 3), colon (n = 3), laryngeal (n = 2), melanoma (n = 1), penal (n = 1), and adrenal (n = 1).

• Argentina
• Fifteen patients were treated at home.
• Two patients were treated as inpatients.

• Bowel function, fecal consistency, presence of diarrhea, nausea and vomiting, and colic were recorded.
• Demographic information, equivalent daily dose of oral morphine, and previous bowel function also were recorded.

• Two patients withdrew from the study.
• Results were confusing, reported as follows.
  • Eight patients had BMs daily, six patients had BMs four times daily, and one patient had BMs on the third day.
  • Four patients needed stimulant laxative in combination, two needed enemas, and one needed a glycerin suppository.
  • Fecal consistency was normal in nine patients, soft in four, and hard in the remaining two.

FBY was effective.

• The sample size was small.
• The taste of FBY was not tolerated by some patients.
• FBY needs to be refrigerated and has a 30-day lifespan.
• The follow-up was short (15 days).
• The study lacked a control group.
• Information concerning FBY's mechanism of action was lacking.
• The long-term efficacy and side effects of FBY were not defined.

The cost of FBY as an intervention was low, at $2.50 per 15 days.

• Two independent authors conducted searches. 
• Data extraction: 102 records were retrieved, 36 abstracts were reviewed, and 12 full-text records were reviewed.
• Seven studies were included in this meta-analysis.
• Targeted data were extracted by authors independently.
• Information collected included demographics, clinic pathology, chemotherapy treatment, efficacy of oxaliplatin-based chemotherapy, and effect of Ca/Mg infusions on oxaliplatin-related neurotoxicity. If a study had more than one grade criteria, only data concerning neurotoxicity incidence graded on the basis of Common Terminology Criteria for Adverse Events (CTCAE) were included.

• FINAL NUMBER STUDIES INCLUDED = 7 studies (4 prospective, randomized, blinded trials ; 3 retrospective clinical trials not blinded or randomized [1 Phase II, 2 phase III]) 
• SAMPLE RANGE ACROSS STUDIES: 27–732 (214 patients in prospective studies, 956 patients in retrospective studies) 
• TOTAL PATIENTS INCLUDED IN REVIEW: Only 1,170 of initial 1,339 analyzed because 2 studies published only a portion of patient results. Final patients included: 1,170 (802 in Ca/Mg group, 368 in control group)
• KEY SAMPLE CHARACTERISTICS: All colorectal diagnoses, four inpatient advanced/metastatic studies, three adjuvant studies. Patients in the Ca/Mg group received before and after oxaliplatin infusions in all studies compared to placebo given or no treatment. Doses or total number of cycles were different. Two studies reported outcomes for acute neuropathy, two for neurotoxicity, one for grade 2 or greater sensory neuropathy, one for toxicity, and one for cumulative neuropathy.

PHASE OF CARE: Advanced

APPLICATIONS: Elder care, palliative care

Meta-analysis indicated that Ca/Mg infusions tended to decrease the incidence of oxaliplatin-induced acute and cumulative neurotoxicity. Based on two studies within this meta-analysis in which patients in the Ca/Mg arm received higher mean doses than patients in the control group, the authors infer that Ca/Mg may enhance patients’ tolerance to oxaliplatin.

• Inconsistent outcomes
• Reliance on CTCAE as outcome measure
• Blinding and randomization not consistent
• Selective outcome reporting 
• Possible bias from several sources
• Data on 214 (18.29%) were from prospective, randomized trials; the remaining data on 956 were from retrospective studies.
• Included those receiving palliative and those receiving adjuvant chemotherapy.
• One chronic neuropathy–related outcome

Ca/Mg infusion tended to reduce the incidence of grade 3 neurotoxicity and total cumulative neurotoxicity in patients with colorectal cancer receiving oxaliplatin. However, these findings must be viewed in light of the heterogeneity of the studies included, differences in neurotoxicity outcome reporting, and recent research studies finding no neuroprotective benefit.

To confirm the effectiveness of the combination of megestrol acetate (MA) and thalidomide for the treatment of cancer cachexia.

Patients were randomly assigned to receive either 160 mg of MA and 50 mg of thalidomide daily or MA alone for eight weeks. Study measures were obtained at baseline and eight weeks.

• The sample was comprised of 93 patients (59% male, 41% female).
• Mean age was 62 years.
• Cancer diagnoses were various tumor types with stage III or IV disease, and 62% of the patients were receiving palliative chemotherapy.

• Single site
• Outpatient
• China

The study has clinical applicability for late effects, survivorship, and palliative care.

This was a randomized, parallel, two-group trial.

• Body weight
• Multidimensional Fatigue Symptom Inventory–Short Form (MFSI-SF)
• European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORT QLQ-C30)
• Visual analog scale (VAS) for appetite
• Grip strength dynamometry
• Serum levels of interleukin-6 (IL-6) or tumor necrosis factor-alpha (TNFα)
• National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0

• Both groups showed improvement in appetite (p < 0.01) and body weight (p = 0.02).
• No significant difference was found between groups in change in appetite.
• Patients receiving both MA and thalidomide showed significant reduction in fatigue, whereas those on MA only had increased fatigue (p < 0.01). 
• Grip strength and IL-6 improved in the patients receiving both drugs compared to those receiving only MA (p < 0.05).
• A portion (7.8%) of the initial sample withdrew because of severe side effects, such as thromboembolism. 
• No difference was found between groups in prevalence of adverse effects.

The combination of MA and thalidomide was associated with improvement in fatigue compared to those receiving only MA. The drug combination was not more effective in treating anorexia and did not show more improvement in body weight.

• The sample size was small, with less than 100 patients.
• The study had risks of bias due to having no control group or blinding.

MA has been shown to have an effect in improving appetite in patients with cancer cachexia, but, as shown, also can have clinically significant side effects. Findings from this study did not show better results for appetite with the addition of thalidomide. This combination appeared to have a positive impact on fatigue. Nurses should be aware that patients taking MA can have side effects, such as thromboembolism, so patients receiving this treatment need to be educated and monitored for adverse events.

To investigate whether sucralfate or aqueous cream reduced acute skin toxicity during radiation therapy to head and neck, breast, or anorectal area (phase A), and to evaluate the effect of hydrogel and dry dressings on most desquamation (phase B)

Patients were randomized into one of six treatment combinations.

1. Aqueous cream/dry dressings
2. Aqueous cream/hydrogel dressings
3. No cream/dry dressings
4. No cream/hydrogel dressings
5. Sucralfate cream/dry dressings
6. Sucralfate cream/hydrogel dressings

Patients randomized to the two creams were advised to apply a thin layer of cream to the treatment area twice daily, from the first day of radiation therapy. All patients were given identical advice about washing the treatment area and provided with a supply of perfume-free soap.

• N = 357 patients remained in study (aqueous cream: 117, sucralfate cream: 120, no cream: 120)
• AGE: Younger than 50 years: 62, 50–59 years: 121, 60–69 years: 103, older than 70 years: 71
• MALES: 95, FEMALES: 262
• KEY DISEASE CHARACTERISTICS: Breast cancer, head and neck cancer, anorectal cancer

• Western General Hospital, Edinburgh, Scotland
• Ninewells Hospital, Dundee, Scotland

• Randomized, controlled double-blind trial

• Baseline skin assessments were recorded, including modified Radiation Therapy Oncology Group (RTOG) acute toxicity scale (assessed at up to seven sites within the treatment field), and a series of erythema readings were taken with a Dia-Stron meter using spectrophotometry. The meter readings in non-irradiated areas were subtracted from those in the treated area. The differences were taken as erythema readings for each patient.
• Patients were asked to complete a quality of life questionnaire (Dermatology Life Quality Index [DLQI]) and a patient diary card, including four Likert scale questions about pain, itching, burning, and sleep disturbance.
• The diary card also required patients to self-assess degree of erythema and desquamation seen within the treatment area using a scoring system.
• All assessments were completed weekly until at least two weeks after completion of radiation therapy or until any skin reaction had totally healed.

Findings presented in the article are phase A only. No consistent differences were found in the severity of skin reactions or levels of discomfort between groups. Patients with higher body mass index, who smoked, or who received concomitant chemotherapy, boost, or bolus during treatment were more likely to develop skin reactions. Sucralfate cream produced significantly lower erythema readings than aqueous cream on adjusted analyses, but the group treated with no cream had even lower readings. No difference was found with survival analysis of time to moist desquamation with treatment cream concurrent chemotherapy, which significantly was associated with worse skin reactions (p = 0.006). Nonsmokers had lower skin toxicity scores than ex-smokers, with smokers having the highest scores for all measures.

No evidence supports prophylactic application of either cream tested for prevention of radiation skin reactions. It is possible to predict which patients are at greatest risk of skin reactions. When consistent skin care instructions to wash with mild soap and water are given, no additional symptomatic benefit is gained by applying cream to the treatment area.

• Cost analysis showed a considerable increase in the cost of supplying sucralfate cream compared with aqueous cream or no cream at all.
• Results apply to a largely Caucasian population (two patients were not Caucasian) and cannot be extrapolated to any other ethnic groups.
• DLQI was found to be a fairly insensitive measure in patients undergoing radiation therapy.
• There was no discussion of the validity and reliability of the modified RTOG scale used for the study.
• The sample size was small for the number of different treatment groups to be analyzed.