Efficacy of Metformin as Preventive Treatment in Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients

Mansoura University

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Peripheral Neuropathy

Treatments

Drug: Metformin

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05351021

2021-375

Details and patient eligibility

About

At present, there are no FDA-approved treatments for chemotherapy-induced neuropathy. Discrete neuro anti-inflammatory effects of metformin support its repurposing as a neuroprotective agent in patients with neurodegenerative diseases. Therefore, this study aims to evaluate the effect of metformin on the amelioration of paclitaxel induced neuropathy in cancer patients.

Enrollment

76 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adult patients (>18 years old)
Early-stage breast cancer patients who will receive adjuvant paclitaxel
Performance status according to Eastern Cooperative oncology group (ECOG) < 2.
Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count ≥100,000/mm3), liver function (serum total bilirubin <1.5 mg/dl), renal function (creatinine<1.5 mg/dl).

Exclusion criteria

Clinical neuropathy at prior to enrollment.
Patients treated with medications that increase the risk of neuropathy like amiodarone, Colchicine, metronidazole, phenytoin.
Patients with a history of hypersensitivity to metformin.
Pregnant or lactating females.
Patients who are using metformin for any other cause.
Patients with Diabetes mellitus.
Receiving vitamin B1, B6, B12 or another vitamin supplemental therapy.
Receiving antidepressants, opioids, adjuvant analgesic agents (eg, anticonvulsants, clonazepam, or mexiletine), topical analgesics, and amifostine.