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IRCT20231218060453N1 IRCT 2023-12-31 Shahid Beheshti University Melatonin and Reduction of the Radiation Dermatitis in Breast Cancer Patients Investigation of the Effect of Melatonin on Reduction of the Grade Three Radiation Dermatitis in Breast Cancer Patients: A Randomized Controlled Trial 2024-01-10 anticipated 40 Complete https://irct.ir/trial/74502 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization process will be performed in block sizes of 4 to balance the number of allocated samples. This process will be done by online internet website of randomization (Sealed Envelope Ltd) available from https://www.sealedenvelope.com and the patients will be randomly assigned to the control (placebo) or intervention (Melatonin) groups with a one-to-one correspondence. Allocation of codes will be blinded. Patients will be enrolled in the study according to the codes, Blinding description: Numbers of randomization process will be placed in the opaque, sealed envelopes with the randomized numbers printed on them. The envelopes will be kept by the blind staff. Allocation of codes will be related to the Melatonin or Placebo and saved in the confidential folder. People involved in the trial including participants(patients), principal investigators, healthcare providers (Physicians, nurses, secratories etc.), family of patients who care for patients during the trial, data collectors, and outcome assessors and data safety and monitoring board do not know if the recipient is receiving the actual drug or placebo and all of them are blinded. Melatonin tablets 20 mg from Jalinous Pharmaceutical company in both intervention and placebo groups are completely similar in terms of color, shape, smell, size and method of administration. Drugs will be delivered to patient as A or B in the same shape, and nobody knows which of them is true drug and which of them is placebo. 3 Radiation Dermatitis. Intervention 1: Intervention group: Breast cancer patients (stage I-Ⅲ) undergoing radiotherapy who take 20 milligram tablet of melatonin every night from first fraction to two weeks after last radiotherapy fraction. Intervention 2: Control group: Breast cancer patients (stage I-Ⅲ) undergoing radiotherapy regimen take one tablet of placebo every night from first fraction to two weeks after last radiotherapy fraction. Yes - There is a plan to make this available What will be shared: Some images of skin regions with radiodermatitis will be published without revealling patients identity. When: After publishing results To whom: Allowed for the public Conditions: Extracting the data of this study data for further investigations in this regard is allowed with citing. Where to obtain: Studying an article after publication or communicating with the corresponding author via email address of fpakniat84@gmail.com How to obtain: Communicating with the corresponding author via email address of fpakniat84@gmail.com Comments:
public Shadi Shafaghi
Masih Daneshvari Hospital. Daar-abad Street. Niavaran Ave.
Tehran Iran (Islamic Republic of) 19575154 +98 21 2712 3000 shafaghishadi@yahoo.com Shahid Beheshti University of Medical Sciences scientific Fatemeh Pakniyat
Masih Daneshvari Hospital. Daar-abad Street. Niavaran Ave.
Tehran Iran (Islamic Republic of) 19575154 +98 21 2712 2175 fpakniat84@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Women aged above 18 years old with breast cancer diagnosis (stage I-Ⅲ) Previous surgery (lumpectomy or mastectomy) Completion of chemotherapy 4 weeks prior to study entry (if it was prescribed for the patient) Radiotherapy regimen with fractionation daily dose of 2 Gy 18 years no limit Female Pregnancy Breast-feeding Serious functional disorders of the liver Epilepsy Diabetes mellitus type 1 or 2 Uncontrolled hypertension Concurrent connective tissue disorders History of chest radiation radiotherapy History of asthma or severe allergic reactions Blood coagulation disorders Concurrent immunosuppressive treatments Taking sedative or anticoagulant drugs at the same time Sensitivity to melatonin L58.0 Acute radiodermatitis Treatment - Drugs Placebo Intervention group: Breast cancer patients (stage I-Ⅲ) undergoing radiotherapy who take 20 milligram tablet of melatonin every night from first fraction to two weeks after last radiotherapy fraction. Control group: Breast cancer patients (stage I-Ⅲ) undergoing radiotherapy regimen take one tablet of placebo every night from first fraction to two weeks after last radiotherapy fraction. Radiation dermatitis grade Ⅲ. Timepoint: Determination of the grade of radiation dermatitis through direct inspection by physician from the beginning of the study to two weeks after the last radiotherapy fraction weekly. Method of measurement: Based on the standard grading criteria of CTCAE (Common Toxicity Criteria for Adverse Events, version 4.03) for cancer clinical trials. Shahid Beheshti University Approved 2021-05-08 Ethics Committee of Shahid Beheshti University Shahid Beheshti University, Shahid Shahriari Square, Evin, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)