Overview

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

Status:
Recruiting
Trial end date:
2022-08-12
Target enrollment:
0
Participant gender:
Female
Summary
At present, there are no FDA-approved treatments for chemotherapy-induced PN .furthermore, the exact mechanism of PN is incompletely understood, however, several potentials include inflammation, promotion of microtubule polymerization and inhibition of depolymerization, and oxidative stress. Discrete neuro anti-inflammatory effects of metformin support its repurposing as a neuroprotective agent in patients with neurodegenerative diseases. Numerous in vitro and in vivo studies have confirmed that metformin ameliorates oxidative damage. Therefore, this study aims to evaluate the effect of metformin on the amelioration of paclitaxel induced PN in breast cancer patients.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Mansoura University
Treatments:
Metformin
Criteria
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.