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 .
Evaluation of the preventive effect of melatonin in reducing the severity of paclitaxel induced peripheral neuropathy compared with placebo in breast cancer patients receiving chemotherapy.
Design
Randomized double blind three arm parallel placebo controlled clinical trial with 80 participants. Allocation ratio 1:1:1 using permuted block randomization. Sequence generated by computer and concealed. Participants, clinicians, outcome assessors and data analysts are blinded.
Settings and conduct
The study will be conducted at Shahid Rajaei Hospital, Babolsar, Iran. Assessments will be performed at baseline, during chemotherapy cycles, and one month after completion.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female patients aged 18 to 70 years with histologically confirmed breast cancer scheduled for ACT chemotherapy. ECOG performance status 0 to 2. Written informed consent required. Exclusion criteria: prior chemotherapy within 6 months, baseline neuropathy, major organ failure, other malignancies, alcohol abuse, pregnancy or breastfeeding.
Intervention groups
Group A1 melatonin 10 mg daily; Group A2 melatonin 20 mg daily; Group B placebo identical capsule. Treatment starts with paclitaxel and continues until one month after 12 weekly cycles
Main outcome variables
Severity of paclitaxel induced peripheral neuropathy assessed by EORTC QLQ CIPN20; nerve conduction study findings.
General information
Reason for update
Acronym
MELTAX Trial
IRCT registration information
IRCT registration number:IRCT20241208063980N1
Registration date:2026-07-21, 1405/04/30
Registration timing:prospective
Last update:2026-07-21, 1405/04/30
Update count:0
Registration date
2026-07-21, 1405/04/30
Registrant information
Name
Mina Heidarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 919 613 5200
Email address
hdn.mina721@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-23, 1405/05/01
Expected recruitment end date
2027-03-20, 1405/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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 .
Public title
Effect of Melatonin on the Prevention of Paclitaxel-Induced Neuropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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
Age
From 18 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganj Afrouz Street
City
Babolsar
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Approval date
2026-06-14, 1405/03/24
Ethics committee reference number
IR.MUBABOL.HRI.REC.1405.111
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
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.
Intervention groups
1
Description
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
Category
Prevention
2
Description
Control group: Placebo capsules identical in appearance to melatonin capsules, administered once daily at bedtime. Treatment duration and schedule are identical to intervention groups.
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The deidentified individual participant data, including baseline characteristics, outcome measures, and adverse events; study protocol; statistical analysis plan; data dictionary.
When the data will become available and for how long
Access will be available from 6 months after publication of the primary study results.
To whom data/document is available
Qualified researchers from academic or research institutions for non commercial purposes.
Under which criteria data/document could be used
Data may be used only for non commercial academic research. Secondary analyses must preserve participant confidentiality and comply with ethical standards
From where data/document is obtainable
Requests should be sent to the principal investigator via institutional email
What processes are involved for a request to access data/document
Requests will be reviewed by the study team. Approved requests will receive de identified datasets after signing a data sharing agreement.