MELADERM-trial: Melatonin cream against acute radiation dermatitis in patients with early breast cancer
Melatonin cream against radiation dermatitis
Abstract
Radiation dermatitis following radiation therapy in the treatment of early breast cancer can lead to discontinuation or prolongation of treatment and an impaired quality of life. Melatonin has been demonstrated to protect against radiation injury. The aim of this study is to investigate whether melatonin can protect against radiation dermatitis when applied topically in women receiving radiation therapy for early breast cancer. This study will be a randomized, placebo-controlled, double-blind controlled trial. Patients will apply the melatonin or placebo preparation topically twice daily for the duration of their radiation therapy. Our objective outcomes will be the Radiation Therapy Oncology Group’s acute radiation morbidity scoring criteria for skin, image analysis of clinical photographs, and use of steroid cream for radiation dermatitis. Subjective outcomes will be quality of life questionnaires developed by the European Organisation for Research and Treatment of Cancer. Outcomes will be measured throughout the five weeks of radiation treatment and be followed up for another three weeks. According to sample-size calculations and inclusion schedule, we intend to include a total of 80 evaluable patients. We will analyze the primary outcomes using parametric and non-parametric tests where applicable. Secondary outcomes will be analyzed by a mixed linear model. Most patients with breast cancer who undergo radiation therapy will develop radiation dermatitis as a result of the therapy. Should our intervention provide better outcomes, many patients could obtain a better quality of life. We expect topical melatonin treatment to have little or no adverse effects, to be easy to apply, and not to interfere with the anti-tumor efficacy of the radiation therapy.
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