Wells, M., Macmillan, M., Raab, G., MacBride, S., Bell, N., MacKinnon, K., . . . Munro, A. (2004). Does aqueous or sucralfate cream affect the severity of erythematous radiation skin reactions? A randomized controlled trial. Radiotherapy and Oncology, 73, 153–162.

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.