Drug Repurposing for the Prevention of Chemotherapy-induced Peripheral Neuropathy (CIPN)
1 other identifier
interventional
68
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2020
CompletedStudy Start
First participant enrolled
November 3, 2020
CompletedFirst Posted
Study publicly available on registry
March 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedJuly 28, 2021
July 1, 2021
1.5 years
November 2, 2020
July 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of grade 2-4 neurotoxicity in both arms
Measured by NCI-CTCAE system
3 months
Secondary Outcomes (4)
Difference in biological markers in both arms.
3 months
Difference in biological markers in both arms.
3 months
Percentage of Qulaity of Life (QOL) deterioration in both arms
3 months
Percentage of other treatment related common adverse events in both arms.
3 months
Study Arms (2)
Metformin group
ACTIVE COMPARATOR1 gm metformin tablet administered twice daily for 3 months
Metformin-free
PLACEBO COMPARATOR1 placebo tablet administered twice daily for 3 months
Interventions
Participants in the intervention group will be administered metformin tablets 2 gm daily during the chemotherapy treatment duration
Participants in the placebo group will be administered metformin free tablet as placebo twice daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
- German University in Cairocollaborator
Study Sites (1)
Cairo University
Cairo, Egypt
Related Publications (3)
Gaballah A, Shafik A, Elhusseiny K, Ashraf M. Chemotherapy-Induced Peripheral Neuropathy in Egyptian Patients: Single Institution Retrospective Analysis. Asian Pac J Cancer Prev. 2018 Aug 24;19(8):2223-2227. doi: 10.22034/APJCP.2018.19.8.2223.
PMID: 30139229BACKGROUNDMao-Ying QL, Kavelaars A, Krukowski K, Huo XJ, Zhou W, Price TJ, Cleeland C, Heijnen CJ. The anti-diabetic drug metformin protects against chemotherapy-induced peripheral neuropathy in a mouse model. PLoS One. 2014 Jun 23;9(6):e100701. doi: 10.1371/journal.pone.0100701. eCollection 2014.
PMID: 24955774BACKGROUNDHershman DL, Lacchetti C, Dworkin RH, Lavoie Smith EM, Bleeker J, Cavaletti G, Chauhan C, Gavin P, Lavino A, Lustberg MB, Paice J, Schneider B, Smith ML, Smith T, Terstriep S, Wagner-Johnston N, Bak K, Loprinzi CL; American Society of Clinical Oncology. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014 Jun 20;32(18):1941-67. doi: 10.1200/JCO.2013.54.0914. Epub 2014 Apr 14.
PMID: 24733808RESULT
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mohamed H. Solayman, PhD. Pharm.
German University in Cairo
- PRINCIPAL INVESTIGATOR
Loay M. Kassem, PhD
Cairo University
- PRINCIPAL INVESTIGATOR
Danira Ashraf Habashy, PhD Pharm.
German University in Cairo
- PRINCIPAL INVESTIGATOR
Sara A. Mosa, Bsc
German University in Cairo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Bsc.
Study Record Dates
First Submitted
November 2, 2020
First Posted
March 4, 2021
Study Start
November 3, 2020
Primary Completion
May 1, 2022
Study Completion
July 1, 2022
Last Updated
July 28, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share