The efficacy of melatonin for the prevention of taxane-induced peripheral neuropathy

Phase 3

Recruiting

Conditions: Taxane-induced peripheral neuropathy in patients with breast cancer.
benign neoplasm of breast
D24.9

Registration Number: IRCT20160310026998N14

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 132

Inclusion Criteria

Patients with breast cancer who are candidate for chemotherapy with taxanes

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.