Phase III Study of Silver Leaf Nylon Dressing vs Standard Care for Reduction of Inframammary Moist Desquamation in Patients Undergoing Adjuvant Whole Breast Radiation Therapy.

AIMS: The primary objective of this study was to assess silver leaf nylon dressings as a prophylactic measure in reducing inframammary fold radiation induced dermatitis in women receiving adjuvant whole breast radiotherapy compared with standard skin care. A secondary objective was to assess if the dressing influenced breast skin-related pain, itching and burning resulting from whole breast radiotherapy. MATERIAL AND METHODS: A prospective randomized trial compared silver leaf nylon dressing worn continuously from the sixth fraction of whole breast radiotherapy until 14 days after therapy completion to standard skin care in patients deemed to be at risk of inframammary radiation induced dermatitis by virtue of a large breast volume or a significant inframammary skin fold in the treatment position. Stratification before randomization was for anthracycline chemotherapy and fractionation scheme. Digital photos of the inframammary region were taken at one week before, the last day of whole breast radiotherapy, and one week after treatment completion. Three observers blinded to treatment arm assessed the images for the presence of moist desquamation and the Radiation Therapy Oncology Group (RTOG) skin toxicity score. Patients completed questionnaires comprising visual analogue scales for pain, itching and burning sensation, and questions regarding which topical skin cream was being used, at the before-mentioned times as well as at baseline and two weeks after completing whole breast radiotherapy. RESULTS: A total of 196 patients completed the study. Moist desquamation occurred in 38% of patients. No difference in incidence or maximum size of moist desquamation or RTOG skin toxicity scores was seen between the treatment arms. However, on the last day of radiation treatment and one week after completion of treatment, patient reports of itching decreased in the experimental arm. At one week before whole breast radiotherapy completion, patients using Glaxal Base cream reported worse burning, those using aloe vera reported worse pain and burning, whereas patients who had not used a moisturizing cream reported less pain. CONCLUSION: Silver leaf nylon dressing use did not demonstrate a decrease in the incidence of inframammary moist desquamation, but did decrease itching in the last week of radiation and one week after treatment completion.