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IRCT20220904055879N1 IRCT 2022-12-10 Shiraz University of Medical Sciences Efficacy of a combination herbal ointment on the prevention of radiation burning in breast cancer 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 2022-11-22 anticipated 100 Complete https://irct.ir/trial/65754 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. 2 radiation dermatitis. Intervention 1: Intervention group: Administration of the Compound herbal remedy including the extracts of pomegranate peel, alum, honey, and oak apple 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. The compound traditional medicine related drug is made by the pharmacist. Intervention 2: Placebo group: The use of a placebo starts from the first session of radiotherapy. 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. 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. The placebo is made by the pharmacist. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information exists
public Shakiba Javadi
Radiotherapy ward. Namazi hospital
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3612 5337 shakibaa89@gmail.com Shiraz University of Medical Sciences scientific Mohammad Mahdi Parvizi
Molecular Dermatology Research Center, Shahid Faghihi Hospital, Zand Avenue, Shiraz, Iran
Shiraz Iran (Islamic Republic of) ۷۱۳۴۸۴۶۱۱۴ +98 71 3212 5592 mmparvizi@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Pathology of breast cancer Breast conserving surgery with or without lymph node dissection The average time interval between chemotherapy and radiation therapy is 3-4 weeks 18 years no limit Female prior radiotherapy prior 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 or drugs addiction Patient unwillingness to participate in the study L59.0 Erythema ab igne [dermatitis ab igne] Treatment - Drugs Placebo Intervention group: Administration of the Compound herbal remedy including the extracts of pomegranate peel, alum, honey, and oak apple 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. The compound traditional medicine related drug is made by the pharmacist. Placebo group: The use of a placebo starts from the first session of radiotherapy. 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. 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. The placebo is made by the pharmacist. Dermatitis Grade. Timepoint: Weekly. Method of measurement: inspection. Shiraz University of Medical Sciences Approved 2022-05-14 esearch Ethics Committees of School of Medicine - Shiraz University of Medical Sciences Radiotherapy ward.,Namazi hospital., Namazi Sq., Shiraz Shiraz Fars Iran (Islamic Republic of)