Curcumin effects on the prevention of peripheral neuropathy-induced by chemotherapy regimen containing paclitaxel in breast cancer patients; a randomized, double blinded and placebo-controlled clinical trial

Phase 3

Not yet recruiting

• Conditions: Breast cancer patients.; (C50-C50); Malignant

• Registration Number: IRCT20180722040556N10
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 March 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

All adult women (18 years and older and less than 65 years old) with non-metastatic breast cancer who received paclitaxel at a dose of 175 mg/m2 every 3 weeks for 4 courses after completing an anthracycline-containing regimen for the first time in the treatment process (New case patients).
The patient must have compliance in taking medication for at least 8 weeks and have enough ability to swallow and consume nanocurcumin capsules orally.
Patients should have the necessary literacy to fill in the questionnairesand also have the necessary cooperation in performing neurological tests.
Patients who do not have any history of liver and kidney failure.

Exclusion Criteria

Patients with a history of any peripheral neuropathy
Patients with a history of coronary artery disease and peripheral vascular disease
All diabetic patients
Pregnancy and breastfeeding
taking anticonvulsant drugs, Tricyclic antidepressants, other neuropathic pain relievers such as duloxetine
Chronic use of cigarettes, drugs or alcohol
Patients with a history of peripheral neuropathy (eg, hereditary, with nutritional factors and paraneoplastic causes)
Those who have received chemotherapy for another malignancy in the past.
Metastasis to the central nervous system or any neurological involvement due to metastasis or tumor pressure
Users of anti-platelet drugs such as aspirin, etc. and oral and injectable anti-thrombosis

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determining and comparing the severity of neuropathy before and after the intervention in each of the intervention and placebo groups. Timepoint: Before the start of chemotherapy - before the second cycle of chemotherapy - before the third cycle of chemotherapy. Method of measurement: Determining and comparing the mean score of NSS, NDS and MNSI index, and comparing neurological tests before and after the intervention.