Drug Repurposing for the Prevention of Chemotherapy-induced Peripheral Neuropathy (CIPN)
NCT ID: NCT04780854
Last Updated: 2021-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
68 participants
INTERVENTIONAL
2020-11-03
2022-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Metformin group
1 gm metformin tablet administered twice daily for 3 months
Metformin
Participants in the intervention group will be administered metformin tablets 2 gm daily during the chemotherapy treatment duration
Metformin-free
1 placebo tablet administered twice daily for 3 months
Placebo
Participants in the placebo group will be administered metformin free tablet as placebo twice daily
Interventions
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Metformin
Participants in the intervention group will be administered metformin tablets 2 gm daily during the chemotherapy treatment duration
Placebo
Participants in the placebo group will be administered metformin free tablet as placebo twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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German University in Cairo
OTHER
Cairo University
OTHER
Responsible Party
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Sara Araby Ramadan Aly Mosa
Bsc.
Principal Investigators
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Mohamed H. Solayman, PhD. Pharm.
Role: STUDY_CHAIR
German University in Cairo
Loay M. Kassem, PhD
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Danira Ashraf Habashy, PhD Pharm.
Role: PRINCIPAL_INVESTIGATOR
German University in Cairo
Sara A. Mosa, Bsc
Role: PRINCIPAL_INVESTIGATOR
German University in Cairo
Locations
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Cairo University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Loay Kassem
Role: primary
References
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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.
Mao-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.
Hershman 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.
Related Links
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Pathophysiology of Chemotherapy-Induced Peripheral Neuropathy.
Other Identifiers
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S-5-2020
Identifier Type: -
Identifier Source: org_study_id
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