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

Cairo University (CU)

Status and phase: Unknown; Phase 2

Conditions: Chemotherapy-induced Peripheral Neuropathy

Treatments: Drug: Metformin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04780854

S-5-2020

Details and patient eligibility

About

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.

Full 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

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups, including a placebo group

Metformin group

Active Comparator group

Description:

1 gm metformin tablet administered twice daily for 3 months

Treatment:

Drug: Metformin

Metformin-free

Placebo Comparator group

Description:

1 placebo tablet administered twice daily for 3 months

Treatment:

Drug: Placebo