NCT04780854

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Chemotherapy-induced Peripheral Neuropathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-11-03
• Primary completion: 2022-05-01
• Completion: 2022-07-01
• First posted: 2021-03-04
• Last updated: 2021-07-28

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study