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IRCT20241208063980N1 IRCT 2026-07-21 Babol University of Medical Sciences Effect of Melatonin on the Prevention of Paclitaxel-Induced Neuropathy MELTAX Trial A Double-Blind Evaluation of the Preventive Effect of Melatonin in Reducing the Severity of Paclitaxel-Induced Peripheral Neuropathy Compared to Placebo in Breast Cancer Patients . 2026-07-23 anticipated 80 Recruiting https://irct.ir/trial/90973 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Method of randomization and description: Permuted block randomization will be used to allocate participants into three study groups with a 1:1:1 allocation ratio. Unit of randomization: Individual patient (each participant will be randomized separately). Stratification: No stratified randomization will be applied in this study. Randomization tool and sequence generation: The random allocation sequence will be generated using computer-based statistical software by an independent statistician who is not involved in patient recruitment, treatment, or outcome assessment. Allocation concealment: Allocation concealment will be ensured through a centralized computer-generated randomization system. The allocation sequence will remain inaccessible to investigators until the time of assignment. Participants and outcome assessors will be blinded to group allocation, Blinding description: This study is double-blind. Participants will not be aware of their treatment allocation (melatonin 10 mg, melatonin 20 mg, or placebo). The study medications will be prepared as identical capsules with identical appearance and coded labeling. The treating clinicians and healthcare providers responsible for patient care will not be informed of group allocation. Outcome assessors who perform neuropathy evaluations (EORTC-QLQ-CIPN20 and EMG/NCS) will be blinded to treatment assignment. Data analysts will also remain blinded to group allocation until completion of the primary analysis. The randomization code will be kept confidential by an independent statistician and will not be disclosed until the end of the study. The principal investigator will not have access to the allocation code during the conduct of the trial. 3 Breast cancer. Intervention 1: Intervention group1: Melatonin 10 mg oral capsule administered once daily at bedtime. Treatment will start from the first cycle of paclitaxel chemotherapy and continue daily until one month after completion of twelve weekly cycles.Intervention group 2: Melatonin 20 mg oral capsule administered once daily at bedtime. Treatment duration and schedule are identical to intervention group. Intervention 2: Control group: Placebo capsules identical in appearance to melatonin capsules, administered once daily at bedtime. Treatment duration and schedule are identical to intervention groups. 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 The decision regarding sharing individual participant data has not yet been finalized and will be determined after study completion and relevant ethical and institutional approvals.
public Mina Heidarian
Shahid Rajaei Hospital, Shariati Street, Babolsar, Mazandaran Province, Iran
Babolsar Iran (Islamic Republic of) ۴۷۱۷۶۴۷۷۴۵ +98 11 3528 9260 hdn.mina721@gmail.com Babol University of Medical Sciences scientific Mina Heidarian
Shahid Rajaei Hospital, Shariati Street, Babolsar, Mazandaran Province, Iran
Babolsar Iran (Islamic Republic of) ۴۷۱۷۶۴۷۷۴۵ +98 11 3528 9260 hdn.mina721@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Female patients with pathologically confirmed breast cancer Patients who are candidates for paclitaxel-containing chemotherapy regimen (ACT). Patients with an ECOG performance status of 0–2. Patients aged between 18 and 70 years Patients who provide written informed consent to participate in the study. 18 years 70 years Female History of other malignancies Chemotherapy within the last 6 months Chronic use of multivitamins, magnesium, or calcium within the last month Cardiac, renal, or hepatic failure Baseline peripheral neuropathy Alcohol abuse or regular alcohol consumption Pregnancy or breastfeeding C50 Malignant neoplasm of breast Prevention Placebo Intervention group1: Melatonin 10 mg oral capsule administered once daily at bedtime. Treatment will start from the first cycle of paclitaxel chemotherapy and continue daily until one month after completion of twelve weekly cycles.Intervention group 2: Melatonin 20 mg oral capsule administered once daily at bedtime. Treatment duration and schedule are identical to intervention group Control group: Placebo capsules identical in appearance to melatonin capsules, administered once daily at bedtime. Treatment duration and schedule are identical to intervention groups. Severity score of paclitaxel induced peripheral neuropathy assessed by the EORTC QLQ CIPN20 questionnaire. Timepoint: Primary outcome will be assessed at baseline prior to initiation of paclitaxel chemotherapy, at the end of each weekly paclitaxel cycle during 12 treatment cycles, and one month after completion of the last paclitaxel cycle. Method of measurement: Assessments will be performed at three time points: before initiation of chemotherapy, including completion of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy Induced Peripheral Neuropathy twenty item version, nerve conduction study and electromyography of the lower limbs, and completion of the food frequency questionnaire; at the end of each weekly paclitaxel cycle including completion of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy Induced Peripheral Neuropathy twenty item version and recording of treatment adherence and concomitant analgesic use; and one month after completion of treatment including repeat of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy Induced Peripheral Neuropathy twenty item version and nerve conduction study and electromyography. Need for analgesic medications during paclitaxel chemotherapy as an indicator of neuropathic symptom severity. Timepoint: Measurement of the secondary outcome, including the need for analgesic medication, will be performed at baseline before initiation of chemotherapy, at the end of each weekly cycle of paclitaxel during twelve treatment cycles, and one month after completion of treatment. Method of measurement: Need for analgesic medications during chemotherapy will be assessed using clinical documentation of analgesic consumption, including non steroidal anti inflammatory drugs and opioid medications, recorded in patient medical records and through patient reported daily drug use logs. Babol University of Medical Sciences Approved 2026-06-14 Ethics committee of Babol University of Medical Sciences Ganj Afrouz Street Babolsar Mazandaran Iran (Islamic Republic of)