Breast cancer patients report reduced sensitivity and pain using a barrier film during radiotherapy – A Danish intra-patient randomized multicentre study

Background and Purpose: Radiodermatitis is a well-known toxicity of radiotherapy and barrier film has been shown to reduce the severity of radiodermatitis. We have validated prior findings in a Danish cohort, using a similar barrier film and patient reported outcomes. Materials and Methods: 101 Danish breast cancer patients were included at three radiotherapy centres. Based on randomization either the lateral or medial part of their chest was covered by Mepitel film; making the patients their own control. The primary endpoint was patient reported symptoms and experience. A secondary endpoint was radiotherapy staff evaluation of dermatitis. Results: Within the skin area covered by film, the patients reported a statistical significant lower level of pain (p < .001), itching (p = 0.005), burning sensation (p = 0.005) as well as edema (p = 0.017) and reduced sensitivity (p < .001). Most patients (76%) would have preferred film on the entire treatment area (p < 0.001) and Mepitel Film as a standard treatment option (84%) (p < 0.001). Patients treated after mastectomy had a significantly lower severity of radiation-induced dermatitis with film at the end of RT compared to standard care (p = 0.005). However, in the blinded staff evaluation, no significant differences were found at follow-up. Conclusions: Patients reported reduced symptoms from the skin with Mepitel Film and the majority would have preferred film as a standard offer to cover their entire treatment area. Especially women treated after mastectomy had a significantly lower level of radiodermatitis and preferred the film over standard care. Keywords: Breast cancer, PRO, Radiotherapy, Mepitel film, Radiodermatiti