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

Abstract

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.

Hydrofilm Polyurethane Films Reduce Radiation Dermatitis Severity in Hypofractionated Whole-Breast Irradiation: An Objective, Intra-Patient Randomized Dual-Center Assessment

“…Dermatitis severities of our patients' control skin compartments were comparable to the recent literature [8,9,34] while the polyurethane-film-covered integument presented with significantly reduced dermatitis rates with a considerable mean reduction of peak CTCAE score by 0.8, and significantly reduced erythema and hyperpigmentation in reflectance spectrophotometry. In particular, the higher dermatitis severity levels (≥ grade 2) could be reduced to approximately a third of patients (9.6% vs. 36.5%) and dermatitis could be completely prevented in approximately three times as many patients compared to standard care (44.6% vs. 14.9%).…”

“…In 78 breast cancer patients, moist desquamation rates were reduced from 26% to 0%, and skin reactions were significantly reduced in those areas covered prophylactically with silicone-dressings [17]: peak skin reactions were grade 0, I, II, and III in 0%, 28%, 64%, and 8%, respectively, in the control areas while 56%, 36%, and 8% of patients developed grade 0, I, and II skin reactions after prophylactic placement of silicone-patches using a comparable study design with an intra-patient randomization. The prophylactic efficacy of Mepitel film was recently reinvestigated in WBI and post-mastectomy radiotherapy [34]. A significant reduction of radiation dermatitis severity was reported in patients undergoing post-mastectomy radiotherapy and in patients treated with a total dose of 50 Gy during WBI.…”

Mepitel Film is superior to Biafine cream in managing acute radiation‐induced skin reactions in head and neck cancer patients: a randomised intra‐patient controlled clinical trial

“…RTOG scores by independent blinded observers revealed a statistically significant decrease in skin reaction severity in favour of Mepitel Film in mastectomy patients and in patients treated with a total dose of 50Gy on the last day of radiation therapy. 19 Another patient cohort that is likely to benefit from better management of radiation-induced skin reactions are head and neck cancer patients who face many challenges in addition to skin reactions and their quality of life during radiation therapy is generally extremely poor 13,14 . We therefore conducted a feasibility study with Mepitel Film in head and neck cancer patients in New Zealand (n = 22) and China (n = 11).…”

Effectiveness of skin protectors and calendula officinalis for prevention and treatment of radiodermatitis: an integrative review

“…Most patients preferred barrier film throughout the treatment area and Mepitel ® film as a standard treatment option. Patients treated after mastectomy had a lower severity of radiodermatitis at the end of radiotherapy with film barrier use compared to standard treatment (28) .…”

“…The study included 101 Danish patients, randomized based on Mepitel ® film application on the lateral or medial part of the breast, with the patients being their own control. The primary endpoint assessed was the patient's report of symptoms and experience, and the secondary endpoint was radiodermatitis assessment by the radiotherapy team (28) .…”