TY - JOUR ID - 39492 TI - Efficacy of Topical Alpha Ointment (Containing Natural Henna) Compared to Topical Hydrocortisone (1%) in the Healing of Radiation-Induced Dermatitis in Patients with Breast Cancer: A Randomized Controlled Clinical Trial JO - Iranian Journal of Medical Sciences JA - IJMS LA - en SN - 0253-0716 AU - Ansari, Mansour AU - Dehsara, Farzin AU - Mosalaei, Ahmad AU - Omidvari, Shapour AU - Ahmadloo, Niloofar AU - Mohammadianpanah, Mohammad AD - Department of Radiation Oncology, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran AD - Student Research Committee, Department of Radiation Oncology, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran AD - Shiraz Institute for Cancer Research, Department of Radiation Oncology, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran AD - Colorectal Research Center, Faghihi Hospital, Shiraz University of Medical Sciences, Shiraz, Iran Y1 - 2013 PY - 2013 VL - 38 IS - 4 SP - 293 EP - 300 KW - Radiation-induced dermatitis KW - Hydrocortisone KW - Breast cancer KW - Radiotherapy DO - N2 - Background: This two-arm, randomized clinical study aimed to compare efficacy between topical Alpha ointment and topical hydrocortisone cream (1%) in the healing of radiation-induced dermatitis in breast cancer patients. Methods: The inclusion criteria comprised newly pathologically proven, locally advanced breast cancer (treated with modified radical mastectomy followed by sequential adjuvant treatments, including chest wall radiotherapy [45-50.4 Gy]) and grade 2 and/or 3 chest wall dermatitis. The exclusion criteria were comprised of any underlying disease or medications interfering with the wound healing process, previous history of chest wall radiotherapy, and concurrent use of chemotherapy. Sixty eligible patients were randomly assigned to use either topical Alpha ointment (study arm, n=30) or topical hydrocortisone cream (1%) (control arm, n=30) immediately after receiving a total dose of 45-50 Gy chest wall radiotherapy. Results: The mean radiation dose was 49.1 Gy in the control arm and 48.8 Gy in the study arm. The mean dermatitis area was 13.54 cm2 in the control arm and 17.02 cm2 in the study arm. Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) (P=0.001). This effect was significant in the second week (P=0.007). In addition, Alpha ointment decreased the patients’ complaints such as pain (P<0.001), pruritus (P=0.009), and discharge (P=0.010) effectively and meaningfully. Conclusion: Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) in our patients with breast cancer. Trial Registration Number: IRCT201206099979N1 UR - https://ijms.sums.ac.ir/article_39492.html L1 - https://ijms.sums.ac.ir/article_39492_2e4493e08bafee805dfd90bd77bed005.pdf ER -