Chemotherapy-Induced Peripheral Neuropathy (Taxane-Induced). Drug-induced polyneuropathy
Conditions
Interventions
Intervention 1: Intervention group: Participants will receive curcumin nanomicelle capsules at a dose of 40 mg once daily with meals for 12 weeks starting from the first day of taxane-based chemothera
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Female patients aged 18 years or older Histologically confirmed breast cancer Planned to receive taxane-based chemotherapy (paclitaxel or docetaxel) ECOG performance status of 0 or 1 No baseline peripheral neuropathy at study entry Written informed consent obtained
Exclusion criteria
Exclusion criteria: Presence of peripheral neuropathy at baseline Uncontrolled diabetes mellitus (HbA1c >8%) Uncontrolled hypothyroidism (TSH >10 mIU/L) Use of medications affecting neuropathy (e.g., gabapentin or pregabalin) Use of oral anticoagulants such as warfarin or DOACs Severe hepatic impairment (ALT or AST >3 times upper limit of normal) Severe renal impairment (CrCl <30 mL/min) Pregnancy or breastfeeding Known hypersensitivity to curcumin or turmeric products Other causes of neuropathy (e.g., neurological or compressive disorders) Use of curcumin-containing supplements prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of chemotherapy-induced peripheral neuropathy assessed by CTCAE v5.0 and EORTC QLQ-CIPN20 questionnaire. Timepoint: Baseline, weeks 4 and 8 during treatment, and at the end of taxane treatment (approximately week 12). Method of measurement: Neuropathy severity will be graded using CTCAE version 5.0 and patient-reported outcomes will be assessed using the EORTC QLQ-CIPN20 questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Health-related quality of life assessed by the EORTC QLQ-C30 questionnaire. Timepoint: At baseline and at week 12. Method of measurement: Change in health-related quality of life from baseline to week 12 assessed by the EORTC QLQ-C30 questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactElnaz Zoghi
Tabriz University of Medical Sciences
Outcome results
None listed