Shaw, S.Z., Nien, H.H., Wu, C.J., Lui, L.T., Su, J.F., & Lang, C.H. (2013). 3M Cavilon No-Sting Barrier Film or topical corticosteroid (mometasone furoate) for protection against radiation dermatitis: A clinical trial. Journal of the Formosan Medical Association.

To investigate the effect of 3M™ Cavilon™ No-Sting Barrier Film and topical corticosteroids on irradiated skin

Thirty-nine post-operative patients with breast cancer were assigned to the three intervention groups using simple randomization. The three treatment groups included 3M barrier film versus no treatment [n = 13], Elomet^® (mometasone furoate [corticosteroid] cream) versus no treatment [n = 9], and Elomet versus 3M barrier film [n = 17]. Each participant’s treatment field was divided in half so that she received both radiodermatitis treatments assigned to the group. Elomet and 3M film barrier were applied every other day, excluding weekends, by the same staff, and the reactions were observed. For patients with more advanced disease, chest wall recurrence, or lymph node involvement, those areas also were irradiated. The skin reactions in the neck and supraclavicular areas were not included in the study. The primary end points were time to onset of grade 1 pruritus, a pain score of 3, and presence of grade 2 dermatitis. The secondary end points were grade 3 radiodermatitis and pain scores by each treatment.

• N = 39  
• AGE = 30–76 years
• MEAN AGE = 51 years
• MALES: 0%, FEMALES: 39%
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Chest wall, remaining breast after conservative surgery, treated skin, untreated skin, post-operative

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: Taiwan

• PHASE OF CARE: Active antitumor treatment

Open-label clinical trial of barrier film or corticosteroid cream, versus no treatment to prevent/reduce grade 1 pruritus, grade 2–3 radiodermatitis, and pain score of 3.

• Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 for dermatitis associated with radiation and for pruritus
• A pain score was collected.
• SPSS software version 10 was used to analyze the data.

The authors recommend using the barrier film starting at the commencement of treatment to reduce friction and irritation, particularly in skin folds and the axilla. However, study findings here do not show an effect on development of radiodermatitis. Once pain and hyperemia occur, the barrier film is discontinued and corticosteroid cream started. The effectiveness of corticosteroid on prevention of radiodermatitis should be investigated further under a lager randomized study.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Key sample group differences that could influence results
• Measurement/methods not well described
• Intervention expensive, impractical, or training needs
• Other limitations/explanation:  The researchers said they used “simple randomization” to assign the participants to the three treatment groups. They did not explain what they meant by “simple randomization.” The number of participants in each treatment group differed. Demographics for the members of each treatment arm were not provided. Some participants were receiving first-line treatment for a new breast cancer. Others were experiencing a recurrence. Some participants had a modified radical mastectomy, and some had breast-conserving surgery. The authors did not report the use of a power analysis to determine the sample size required to accurately identify statistically significant differences between the treatments, nor the expected effect size of the intervention. It is unlikely that 13 participants in each treatment arm would provide enough power to detect significant differences. The participants in the 3M barrier film versus no treatment and the Elomet (mometasone furoate [steroid] cream) versus no treatment arms served as their own control. The participants in the Elomet versus 3M barrier film arm did not have a control. The volume and type of tissue in each half of the treatment field may not have been identical. The skin dose in each half may have differed and was not reported in this article. Inter-rater reliability was not reported. The method of measuring pain score was not reported.  A pain score of 3 was an endpoint, but the range was not identified.

The effectiveness of corticosteroids on prevention of radiodermatitis should be investigated further in a large, randomized, controlled clinical trial with adequate power to detect clinically significant differences and controlling for confounding factors.