Drug Repurposing for the Prevention of Chemotherapy-induced Peripheral Neuropathy (CIPN)

July 27, 2021 updated by: Sara Araby Ramadan Aly Mosa, Cairo University
Chemotherapy cause many adverse events including induction of peripheral neuropathy. Metformin, the AMPK activator, was found to have protective effect against chemotherapy induced peripheral neuropathy in mouse model and in clinical trials as well. There are different hypothesized mechanisms through which metformin does the protective effect. Such as enhancing mitochondrial activity, reduction of ROS and nitric oxide and activation of AMPK.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Chemotherapy can cause a variety of side effects. One of the most common side effects is Chemotherapy induced peripheral neuropathy (CIPN), it commonly caused by Paclitaxel chemotherapy which is usually used in the treatment of breast cancer. Metformin which is known as a safe anti-diabetic drug, was found to have a protective effect on neurons. It gave positive results in chemotherapy induced peripheral neuropathy in mouse models and in some clinical trials

Study Type

Interventional

Enrollment (Anticipated)

68

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 Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Cairo University
        • Contact:
          • Loay Kassem
        • Principal Investigator:
          • Loay Kassem

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age (18-75) male and female patients
  • Scheduled to be treated with single agent Paclitaxel
  • Performance status according to Eastern Cooperative oncology group (ECOG) < 2.
  • Patients who are willing and able to review and provide written consent, patients who can read the questionnaires

Exclusion Criteria:

  • Previous exposure to chemotherapy drugs that cause neuropathy, patients treated with medications that increase the risk of neuropathy like amiodarone, Colchicine, metronidazole, phenytoin.
  • Patients with impaired liver functions or kidney functions.
  • Patients with a history of any serious adverse events or interaction or hypersensitivity to Metformin.
  • Pregnant or lactating females.
  • Patients who are using metformin for any other cause.
  • Patients with sensory or motor neuropathy of any grade prior to enrollment.

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
Active Comparator: Metformin group
1 gm metformin tablet administered twice daily for 3 months
Drug: Metformin
Participants in the intervention group will be administered metformin tablets 2 gm daily during the chemotherapy treatment duration
Other Names:
  • Cidophage
  • N,N-dimethylbiguanide
Placebo Comparator: Metformin-free
1 placebo tablet administered twice daily for 3 months
Drug: Placebo
Participants in the placebo group will be administered metformin free tablet as placebo twice daily
Other Names:
  • inactive pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of grade 2-4 neurotoxicity in both arms
Time Frame: 3 months
Measured by NCI-CTCAE system
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in biological markers in both arms.
Time Frame: 3 months
Measurement of Nerve growth factor (NGF)
3 months
Difference in biological markers in both arms.
Time Frame: 3 months
Measurement of Malondialdehyde (MDA)
3 months
Percentage of Qulaity of Life (QOL) deterioration in both arms
Time Frame: 3 months
Measured using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) questionnaire. The higher the score, the better the quality of life.
3 months
Percentage of other treatment related common adverse events in both arms.
Time Frame: 3 months
Graded using NCI-CTCAE system
3 months

Collaborators and Investigators

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

Sponsor

Cairo University

Collaborators

German University in Cairo

Investigators

  • Study Chair: Mohamed H. Solayman, PhD. Pharm., German University in Cairo
  • Principal Investigator: Loay M. Kassem, PhD, Cairo University
  • Principal Investigator: Danira Ashraf Habashy, PhD Pharm., German University in Cairo
  • Principal Investigator: Sara A. Mosa, Bsc, German University in Cairo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

November 3, 2020

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

March 1, 2021

First Posted (Actual)

March 4, 2021

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-5-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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