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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-12

Study Completion Date

2022-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Neuropathy Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group I (metformin group)

who will receive adjuvant paclitaxel in addition to metformin tablets (1700 mg daily) during the chemotherapy treatment duration.

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

cidophage 850 gm twice daily

Group II (control group)

who will receive adjuvant weekly paclitaxel.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo twice daily for treatment period

Interventions

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Metformin

cidophage 850 gm twice daily

Intervention Type DRUG

Placebo

placebo twice daily for treatment period

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes