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

March 7, 2023 updated by: Noha Mansour, Mansoura University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (metformin group)
who will receive adjuvant paclitaxel in addition to metformin tablets (1700 mg daily) during the chemotherapy treatment duration.
Drug: Metformin
cidophage 850 gm twice daily
Placebo Comparator: Group II (control group)
who will receive adjuvant weekly paclitaxel.
Drug: Placebo
placebo twice daily for treatment period

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2022

Primary Completion (Actual)

October 30, 2022

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

April 14, 2022

First Submitted That Met QC Criteria

April 27, 2022

First Posted (Actual)

April 28, 2022

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-375

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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