Spots Global Cancer Trial Database for Mepitel Film Treatment for the Prevention and Cutaneous Toxicity Due to Radiotherapy

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Trial Identification

Brief Title: Mepitel Film Treatment for the Prevention and Cutaneous Toxicity Due to Radiotherapy

Official Title: Mepitel Film vs Standard of Care for the Radiotherapy Prevention and Cutaneous Toxicity in Patients With Post-surgery Breast Cancer

Study ID: NCT02741258

Conditions

Post-surgery Radiotherapy

Interventions

Mepitel Film

skin cream

Study Description

Brief Summary: This is a randomized study, mepitel vs standard of care for the prevention and skin toxicity due to radiotherapy in patients with post-surgery breast cancer. Mepitel film will be placed on the skin of the patients just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of toxicities.

Detailed Description: For patients randomized in the mepitel arm: Mepitel film will be placed on the patients' skin just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of the toxicities. In case of new skin toxicities appearance the patient will be retreated with mepitel. For patients randomized in the standard of treatment arm: Patients will be treated with aqueous (Excipial U hydrolotion) or antiseptic (Flammazine o Ialugen Plus) cream in case of skin erythema. In case of new skin toxicities appearance the patient will be retreated with standard of care treatment.