Taxane-induced peripheral neuropathy in patients with breast cancer. benign neoplasm of breast
Conditions
Interventions
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
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Patients with breast cancer who are candidate for chemotherapy with taxanes
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public Contactsaba Ghaffary
Tabriz University of Medical Sciences
Outcome results
None listed