MELADERM-trial: Melatonin cream against acute radiation dermatitis in patients with early breast cancer

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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.