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IRCT20160310026998N14 IRCT 2023-04-11 Tabriz University of Medical Sciences The efficacy of melatonin for the prevention of taxane-induced peripheral neuropathy METANE Evaluating the effectiveness of melatonin for the prevention of taxane-induced peripheral neuropathy in patients with breast cancer: A double-blinded randomized clinical trial 2023-04-03 anticipated 132 Complete https://irct.ir/trial/68981 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 132 patients with breast cancer who are candidates for chemotherapy with taxanes and referred to the clinic or hospital ward of Shahid Ghazi Hospital will be divided into two groups (intervention and control) after screening based on inclusion and exclusion criteria. A simple randomization procedure will be performed based on a table of random numbers, Blinding description: Patients with breast cancer who are qualified to participate in the study based on the inclusion and exclusion criteria will enter the study after signing informed consent. Participants will not be aware of the type of drug (either melatonin or placebo). Also, researcher and physicians who refer the patients to the researcher will not be informed about the type of drug (either melatonin or placebo). Only the monitoring committee of the clinical study is informed. 3 Taxane-induced peripheral neuropathy in patients with breast cancer. Intervention 1: Intervention group: Patients will receive 15 mg of melatonin (3 tablets of melatonin 5 mg - JALINOUS Co.) daily at bedtime for 12 weeks. The first day of chemotherapy with taxanes will be the first day of melatonin use. Intervention 2: Control group: Patients will receive placebo daily at bedtime for 12 weeks. The first day of chemotherapy with taxanes will be the first day of placebo use. 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 There is no more data.
public saba Ghaffary
Shahid Ghazi hospital, Tabriz University of Medical Sciences, Daneshgah street
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3336 5010 ghaffarys@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Saba Ghaffry
Shahid Ghazi hospital,Tabriz University of Medical Sciences, Daneshgah street
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3336 5010 ghaffarys@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with breast cancer who are candidate for chemotherapy with taxanes 18 years 85 years Female History of neuropathy Use of medications that can cause neuropathy such as statins, colchicine, zidovudine, penicillamine, platinum derivatives (cisplatin, oxaliplatin), and vinca alkaloids History of fibromyalgia, rheumatoid arthritis, osteoarthritis, hypothyroidism, sleep apnea, autoimmune diseases, diabetes mellitus, heart failure, myocardial infarction, uncontrolled hypertension, unstable angina, stroke, and seizure in the previous year History of allergy to melatonin Alcohol intake Active infection (such as COVID-19 or other respiratory infections) History of prior chemotherapy Severe kidney or liver failure Presence of other malignancies Prediction of patient nonadherence D24.9 benign neoplasm of breast Treatment - Drugs Treatment - Drugs Intervention group: Patients will receive 15 mg of melatonin (3 tablets of melatonin 5 mg - JALINOUS Co.) daily at bedtime for 12 weeks. The first day of chemotherapy with taxanes will be the first day of melatonin use. Control group: Patients will receive placebo daily at bedtime for 12 weeks. The first day of chemotherapy with taxanes will be the first day of placebo use. Frequency of peripheral neuropathy. Timepoint: At baseline, after 12-week intervention, and 3 months after intervention termination. Method of measurement: The Michigan Neuropathy Screening Instrument (MNSI), DN4 questionnaire, neurofilaments and Diapazone test. Adverse effects of taxanes. Timepoint: At baseline, after the 12-week intervention, and 3 months after intervention termination. Method of measurement: The Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) questionnaire. Anxiety in patients. Timepoint: At baseline, after 12-week intervention, and 3 months after intervention termination. Method of measurement: PROMIS Emotional Distress – Anxiety – Short Form. Tabriz University of Medical Sciences Approved 2023-02-20 Ethics Committee at Tabriz University of Medical Sciences Shahid Ghazi hospital, Tabriz University of Medical Sciences, Daneshgah street Tabriz East Azarbaijan Iran (Islamic Republic of)