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

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Abstract
Introduction Patients 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. Methods A 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. Results The 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. Conclusion In 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.

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