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IRCT20160131026282N2 IRCT 2023-09-14 Mashhad University of Medical Sciences Evaluation of the effects of a lotion containing Althaea officinalis, Ocimum basilicum, and Apium graveolensin extracts in the prevention and treatment of radiation therapy-induced dermatitis in breast cancer patients Evaluation of the effects of a lotion containing Althaea officinalis, Ocimum basilicum, and Apium graveolensin extracts in the prevention and treatment of radiation therapy-induced dermatitis in breast cancer patients: A Placebo-Controlled, Double-Blind, Randomized Clinical Trial 2023-10-23 anticipated 72 Complete https://irct.ir/trial/61183 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by a simple method using random numbers created by computer software. By considering the numbers for two groups, randomization is done. For blinding, the patient will receive the drug (intervention or comparison group) in sealed envelopes that are coded. Coding is done by one of the colleagues of the project and the doctor, evaluator, and patient are blinded, Blinding description: The number of letter envelopes is recorded with an aluminum wrapper (in order to make the contents of the envelopes unclear). Each of the randomly created sequences is recorded on a card, and the cards are placed inside the letter envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of the participants, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed. The patient receives the medication (intervention or control group) in sealed envelopes that are coded. Coding is done by one of the colleagues of the project and the doctor, evaluator, and patient are blinded. 0 (exploratory trials) Radiation therapy-induced dermatitis in breast cancer patients. Intervention group: A standardized herbal lotion is applied on the affected area twice a day at least 2 hours before and after radiation therapy. The patients are requested not to wear cloth before 10 min of lotion application and not to wash a area at least for 2 hours. The lotion is administered from the firs day of radiation therapy to 2 weeks after the end of the therapy (for 6 weeks).. No - There is not a plan to make this available Justification or reason for not sharing IPD is No other information is available.
public Behjat
University Campus, Azadi Square, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3180 1268 Javadib@mums.ac.ir Mashhad University of Medical Sciences scientific Behjat
University Campus, Azadi Square, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3180 1268 Javadib@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) patients (women) >18 years, undergone breast Lumpectomy surgery for breast cancer and a fractionation regimen of at least 42 Gy. Patients capable of finishing radiotherapy and contributing to the research team. The patient is personally capable of lotion application and learning the research instructions. Patient who have not undergone radiotherapy previously. 18 years 70 years Female Patients with ulcers or unhealed wounds, burns, infections, and previous skin complications at the radiotherapy site. Patients who undergo chemotherapy or hormone therapy (adjuvant or neoadjuvant) at the same time Using skin medicines to treat skin diseases other than dermatitis caused by radiation therapy Patients taking high-dose non-steroidal anti-inflammatory drugs. Presence of connective tissue disorders or collagen disorders Allergy to the herbs used in the intervention lotion or any of the components of the formulation Allergy to the routine treatment used in the treatment of dermatitis underlying disease such as diabetes Smoking Taking radiation sensitizing drugs L58 Radiodermatitis Treatment - Drugs Intervention group: A standardized herbal lotion is applied on the affected area twice a day at least 2 hours before and after radiation therapy. The patients are requested not to wear cloth before 10 min of lotion application and not to wash a area at least for 2 hours. The lotion is administered from the firs day of radiation therapy to 2 weeks after the end of the therapy (for 6 weeks). The severity of the radiation therapy-induced dermatitis. Timepoint: At the baseline and after 2, 4 and 6 weeks. Method of measurement: RTOG/EORTC toxicity criteria. Evaluating the severity of dermatitis symptoms (level of pain, itchiness and burning as well as the effect on day to day life). Timepoint: At the baseline and after 2, 4 and 6 weeks. Method of measurement: The radiation-induced skin reaction assessment scale (RISRAS). Mashhad University of Medical Sciences Approved 2022-08-27 The ethics committee of Mashhad University of Medical Sciences School of Pharmacy, Pardis University Campus ,Azadi Square, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)