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IRCT20230509058138N1 IRCT 2023-12-18 Babol University of Medical Sciences The effect of quercetin on dermatitis caused by radiotherapy in breast cancer Evaluating the intensity of dermatitis caused by radiotherapy in breast cancer patients with or without using quercetin 2024-02-20 anticipated 92 Complete https://irct.ir/trial/70233 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: During this double-blind randomized clinical trial, patients are divided into two random groups using blocks 4 and 10. Medicines are placed in tubes of the same shape and without the researcher and the patient knowing the contents of each tube, the medicines are given to the patients with the help of a nurse, Blinding description: During this double-blind clinical trial, the participants (patients), the researcher, the outcome assessor and the data analyst have been kept blind. Ointments containing Quercetin and placebo are placed in tubes of the same shape, by a colleague not involved in the implementation process of the project, and without the researcher and the patient knowing the contents of each tube, the medicines are given to the patients with the help of a nurse. 3 Dermatitis. Intervention 1: Intervention group: Women with breast cancer in the age range of 30 to 70 years who underwent surgery (lumpectomy) and chemotherapy and after 3 to 4 weeks of chemotherapy, referred to receive adjuvant radiotherapy, are included in the study. The combination of quercetin from Sigma company is given to patients at a dose of 0.2%. After each radiotherapy session, patients are asked to apply the drug twice a day (once after radiotherapy and once at night) for 6 weeks using rubbing method. Also, before each radiotherapy session, patients should use Dove soap to wash the treatment area so that no trace of the drug remains. Intervention 2: Control group: The placebo contains carboxymethyl cellulose with food coloring that is similar in color to the quercetin compound. After each radiotherapy session, patients are asked to apply the drug twice a day (once after radiotherapy and once at night) for 6 weeks using rubbing method. Also, before each radiotherapy session, patients should use Dove soap to wash the treatment area so that no trace of the drug remains. 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 information available
public Maryam Ramezanpour
Gangafrouz Ave., Abolhasani Blvd., Babol Town
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 21 8846 2826 maryam.rmp81@gmail.com Babol University of Medical Sciences scientific Dariush Moslemi
Gangafrouz Ave., Abolhasani Blvd., Babol Town
Babol Iran (Islamic Republic of) 47176-47745 +98 11 2523 1517 moslemid@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) women with breast cancer who are between 30 to 70 years old they underwent breast lumpectomy surgery after 3-4 weeks of surgury, they came for radiotherapy 30 years 70 years Female patients who have an underlying disease and a history of skin inflammation patients who are in stage 4 or are undergoing radiotherapy for palliation patients with Modified Radical Mastectomy must not be included in the study. Patients with a history of severe allergy L58.0 Acute radiodermatitis Treatment - Drugs Treatment - Drugs Intervention group: Women with breast cancer in the age range of 30 to 70 years who underwent surgery (lumpectomy) and chemotherapy and after 3 to 4 weeks of chemotherapy, referred to receive adjuvant radiotherapy, are included in the study. The combination of quercetin from Sigma company is given to patients at a dose of 0.2%. After each radiotherapy session, patients are asked to apply the drug twice a day (once after radiotherapy and once at night) for 6 weeks using rubbing method. Also, before each radiotherapy session, patients should use Dove soap to wash the treatment area so that no trace of the drug remains. Control group: The placebo contains carboxymethyl cellulose with food coloring that is similar in color to the quercetin compound. After each radiotherapy session, patients are asked to apply the drug twice a day (once after radiotherapy and once at night) for 6 weeks using rubbing method. Also, before each radiotherapy session, patients should use Dove soap to wash the treatment area so that no trace of the drug remains. Severity of radiotherapy-induced dermatitis according to RTOG classification. Timepoint: The severity of radiation dermatitis is evaluated once a week from the time of entering the study until the completion of the radiotherapy treatment. Method of measurement: Based on the criteria of Radiation Therapy Oncology Group. The time which symptoms of dermatitis develop. Timepoint: Once a week from the beginning of the study to the end of the radiotherapy duration. Method of measurement: We record the time when the symptoms of dermatitis developed in the weekly examination according to the opinion of the specialist who evaluates the patients. Severity of patients' pain. Timepoint: Once a week from the beginning of the study to the end of the radiotherapy duration. Method of measurement: We record the change in pain intensity in the weekly examination according to the opinion of the specialist who evaluates the patients. The pain intensity of the patients is measured using the Visual Analogue Scale index. Babol University of Medical Sciences Approved 2023-12-10 Health Research Institute - Babol University of Medical Sciences Gangafrouz Ave., Abolhasani Blvd., Babol Town Babol Mazandaran Iran (Islamic Republic of)