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

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Collaborator: German University in Cairo
• Treatments: Metformin

Criteria

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.