Comparing Dermolina-Henna Cream with Mometasone Cream in Improving Radiodermatitis Among Patients with Breast Cancer: A Randomized Active-Control Double-Blind Clinical Trial.

Objectives: Radiotherapy is one of the treatments used for different types of cancer. Acute radiodermatitis is one of its most common complications. Despite the high prevalence of radiodermatitis, few studies investigated how to prevent or treat this complication. Hence, a standard treatment has not been introduced so far. We sought to evaluate the efficacy of Dermolina-Henna cream, a new polyherbal formulation, compared to Mometasone cream for alleviating acute radiodermatitis among breast cancer patients. Design: Randomized active-control double-blind clinical trial. Setting/Location: The oncology clinic of Shohaday-e Tajrish Hospital (Tehran, Iran). Subjects: Women older than 18 years with breast cancer undergoing radiotherapy. Interventions: Patients were instructed to apply a thin layer of Dermolina-Henna or Mometasone cream once daily on their lesions at least 3 h after radiotherapy for 4 weeks, and if grade I or II radiodermatitis developed, also afterward. Patients were visited weekly until end of study at after 4 weeks. Radiation Therapy Oncology Group standard questionnaires were evaluated and recorded every week as the primary outcome. Outcome measures: Primary outcome was defined as evaluating the efficacy of Dermolina-Henna cream to change the radiodermatitis grade, while the level of patients' satisfaction and the rate of adverse events recorded by patients were secondary outcomes. Results: The trends on decrease in number of lesions, erythema, radiodermatitis grade, burning sensation, pain, and itchiness were statistically significant for each treatment, separately ( p  < 0.001), except for radiodermatitis grade in Mometasone group ( p  = 0.4). Dermolina-Henna was significantly better than Mometasone in alleviating burning sensation ( p  < 0.001) and itchiness ( p  = 0.041). Approximately 3.7% of patients showed adverse events and 3.7% declared dissatisfaction in both groups. Conclusions: In summary, we showed that Dermolina-Henna cream and Mometasone cream were significantly effective in decreasing severity of radiodermatitis symptoms among patients with breast cancer. Dermolina-Henna cream was significantly superior to Mometasone cream in alleviating burning and itchiness. Clinical Trial Registration Number: IRCT20200115046144N1.