Clinical trial · Interventional
Drug Repurposing for the Prevention of Chemotherapy-induced Peripheral Neuropathy (CIPN)
NCT04780854CI-TRIAL-00052945unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Metformin group
- description
- 1 gm metformin tablet administered twice daily for 3 months
- interventionNames
- Drug: Metformin
- type
- PLACEBO_COMPARATOR
- label
- Metformin-free
- description
- 1 placebo tablet administered twice daily for 3 months
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Percentage of grade 2-4 neurotoxicity in both arms
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDGaballah 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 30139229
- BACKGROUNDMao-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 24955774
- RESULTHershman 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 24733808