Efficacy of a combination herbal ointment (pomegranate peel, alum, honey, and oak apple) on the prevention of radiation-induced dermatitis during adjuvant radiation in patients with breast cancer after conservative breast surgery: A randomized controlled trial

Efficacy of a combination herbal ointment (pomegranate peel, alum, honey, and oak apple) on the prevention of radiation-induced dermatitis during adjuvant radiation in patients with breast cancer after conservative breast surgery

A controlled clinical trial with a parallel groups , double-blind, randomized, phase 2 on 100 patients. Random allocation software was used for randomization

It was conducted on under radiotherapy breast-cancer patients In Namazi Hospital in Shiraz

Inclusion criteria: Patient with breast cancer confirmed by pathology, Breast-conserving surgery with or without lymph node dissection, The average time interval between chemotherapy and radiation therapy is 3-4 weeks*** Exclusion criteria: prior radiotherapy, Concurrent chemotherapy, skin involvement, connective tissue disease, diabetes nor chronic kidney disease, rash, ulcer or skin infection in the site of radiation, systemic infection, Existing nonhealing scar in the site of radiation, concomitant local treatment, cigarette nor drugs addiction, Patient unwillingness to participate in the study

Intervention group: drug use starts from the first radiotherapy session. It is applied twice a day with a thickness of 1 to 2 mm, at least 6 hours apart, on the radiation surface, the limits of which are determined by the treatment design. Due to the possibility of creating a bolus effect, patients are advised to use the ointment at least 4 hours before radiotherapy and to use the ointment for a week after the completion of radiotherapy. Placebo group: The use of a placebo starts from the first radiotherapy session. It is applied twice a day, at least 6 hours apart, with a thickness of 1 to 2 mm on the radiation surface, whose limits are determined by the treatment design.

Grade of radiation dermatitis

Randomization allocation is done based on the permutation block table obtained from the Random allocation software (Version 1.00, Isfahan University of Medical Sciences, Iran). For this purpose, blocks of four are used. For this purpose, patients are randomly divided into two drugs (A) and placebo (B) groups. Dark-colored envelopes are used to allocate concealment.

In this study, the patient, the treatment team, and the clinical assessor are blinded. For this purpose, the drug and the placebo are made in the same color and smell and are packed in the same containers. To name the drug, letters (A) are used for the drug and (B) for the placebo