Clinical Research Directory

Randomized Phase III Trial With Mepitel Film for the Prophylaxis of Radiation Dermatitis in Breast Cancer Patients

Sponsor: Sunnybrook Health Sciences Centre

Summary

Breast cancer patients undergoing adjuvant radiotherapy commonly experience radiation-induced skin reactions which adversely impact quality of life. Importantly, patients receiving chest wall radiation or patients with large breasts are more likely to have worse skin reactions. In the last decade, there have been no significant advances in preventing or treating radiation-induced skin toxicities. In response to the lack of evidence, Sunnybrook investigators previously conducted a pilot study (REB #294-2018) of Mepitel Film and preliminary results showed improvements in high grade skin reactions. Mepitel Film has not been widely adopted in North America as more evidence is needed. The validate the efficacy of the film compared to the standard of care, a study testing the efficacy of the film is proposed. In the study, 216 patients will be randomized (2:1) to receive either the film or the institution's current skin treatments and all patients will have their skin assessed.

Official title: A Randomized Phase III Trial With Mepitel Film for the Prophylaxis of Radiation Dermatitis in Adjuvant Breast Radiation Treatment

Key Details

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Locations (1)