Status:
UNKNOWN
Drug Repurposing for the Prevention of Chemotherapy-induced Peripheral Neuropathy (CIPN)
Lead Sponsor:
Cairo University
Collaborating Sponsors:
German University in Cairo
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 neuropat...
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 usual...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04780854
Start Date
November 3 2020
End Date
July 1 2022
Last Update
July 28 2021
Active Locations (1)
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1
Cairo University
Cairo, Egypt