Phase III Randomized Pair Comparison of a Barrier Film vs. Standard Skin Care in Preventing Radiation Dermatitis in Post-lumpectomy Patients with Breast Cancer Receiving Adjuvant Radiation Therapy

Abstract

IntroductionPatients undergoing adjuvant radiotherapy to the breast often experience radiation dermatitis ranging from mild erythema to moist desquamation. In post-lumpectomy patients, the axilla and inframammary fold are at an increased risk for friction dermatitis. Dermatitis can impact patients’ quality-of-life and may require treatment break/cessation. Our objectives are to assess the efficacy of 3M Cavilon Barrier Film (BF) in preventing and/or delaying the onset of grade-two dermatitis and reducing patient-reported sensation scores.MethodsA total of 55 patients were randomized to receive BF on the medial or lateral breast. BF was applied twice weekly during treatment. Skin toxicity was evaluated weekly by a blinded clinical investigator using the Skin Toxicity Assessment Tool (STAT) and the modified Radiation Therapy Oncology Group Visual Assessment Score (RTOG VAS). On day one, baseline photographs were taken; seven-to-ten days post-treatment, patients returned for photographs, the STAT/RTOG VAS, and patient-opinion questions in the form of the global questionnaire.ResultsThe paired analysis found BF did not significantly reduce dermatitis either during or post-treatment. However, the unpaired analysis found significantly reduced RTOG VAS on the lateral compartment during treatment (BF:0.91 vs. Control:1.21, p = 0.0408). This difference resolved post-treatment. Additionally, BF was able to reduce pruritus (p = 0.047) on the medial components and burning sensations on the lateral components (p = 0.035). There was no significant difference between the time-to-onset or proportion of patients who developed grade-two dermatitis.ConclusionIn an unpaired analysis, BF significantly reduced dermatitis on the lateral compartment during treatment. Additionally, BF significantly reduced pruritus and burning sensations. A larger study using a more reliable scoring method is required to clarify the effect of BF on radiation-associated skin toxicity.