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

NCT04780854 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2021-07-28

No results posted yet for this study

Summary

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.

Conditions

  • Chemotherapy-induced Peripheral Neuropathy

Interventions

DRUG

Metformin

Participants in the intervention group will be administered metformin tablets 2 gm daily during the chemotherapy treatment duration

DRUG

Placebo

Participants in the placebo group will be administered metformin free tablet as placebo twice daily

Sponsors & Collaborators

  • German University in Cairo

    collaborator OTHER

  • Cairo University

    lead OTHER

Principal Investigators

  • Mohamed H. Solayman, PhD. Pharm. · German University in Cairo

  • Loay M. Kassem, PhD · Cairo University

  • Danira Ashraf Habashy, PhD Pharm. · German University in Cairo

  • Sara A. Mosa, Bsc · German University in Cairo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-03
Primary Completion
2022-05-31
Completion
2022-07-31
FDA Drug
Yes

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04780854 on ClinicalTrials.gov