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

Phase 2

Completed

• Conditions: Peripheral Neuropathy; Breast Cancer
• Interventions: Drug: Placebo; Drug: Metformin

• Registration Number: NCT05351021
• Lead Sponsor: Mansoura University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-12
• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-04-28
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (control group)	Placebo	who will receive adjuvant weekly paclitaxel.
Group I (metformin group)	Metformin	who will receive adjuvant paclitaxel in addition to metformin tablets (1700 mg daily) during the chemotherapy treatment duration.

Primary Outcome Measures

Name	Time	Method
The incidence of grade II or more peripheral neuropathy at the end of paclitaxel treatment	8 weeks	Grading of paclitaxel induced peripheral neuropathy will be done using NCI-CTCAE version (4.03)

Secondary Outcome Measures

Name	Time	Method
the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale	8 weeks	Patient's QOL will be assessed using the validated Arabic version of FACT-GOG-NTX subscale
Serum biomarkers level in (ng/mL)	8 weeks	Nerve growth factor Biomarkers levels will be measured using commercial ELISA kits.
Pain Severity	8 weeks	The severity of neuropathic pain will be assessed using the Arabic version of the Brief Pain Inventory Short Form (BPI-SF)
Time to develop grade 2or 3 PIPN	8 weeks	The time from randomization till development of grade II or III PN will be recorded for all patients included in the study.

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Egypt