Clinical trial · Interventional
Efficacy of Metformin as Preventive Treatment in Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
NCT05351021CI-TRIAL-00064585completedPhase 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)
At present, there are no FDA-approved treatments for chemotherapy-induced neuropathy. Discrete neuro anti-inflammatory effects of metformin support its repurposing as a neuroprotective agent in patients with neurodegenerative diseases. Therefore, this study aims to evaluate the effect of metformin on the amelioration of paclitaxel induced neuropathy in cancer patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| 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
- EXPERIMENTAL
- label
- Group I (metformin group)
- description
- who will receive adjuvant paclitaxel in addition to metformin tablets (1700 mg daily) during the chemotherapy treatment duration.
- interventionNames
- Drug: Metformin
- type
- PLACEBO_COMPARATOR
- label
- Group II (control group)
- description
- who will receive adjuvant weekly paclitaxel.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- The incidence of grade II or more peripheral neuropathy at the end of paclitaxel treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (\>18 years old) * Early-stage breast cancer patients who will receive adjuvant paclitaxel * Performance status according to Eastern Cooperative oncology group (ECOG) \< 2. * Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count ≥100,000/mm3), liver function (serum total bilirubin \<1.5 mg/dl), renal function (creatinine\<1.5 mg/dl). Exclusion Criteria: * Clinical neuropathy at prior to enrollment. * Patients treated with medications that increase the risk of neuropathy like amiodarone, Colchicine, metronidazole, phenytoin. * Patients with a history of hypersensitivity to metformin. * Pregnant or lactating females. * Patients who are using metformin for any other cause. * Patients with Diabetes mellitus. * Receiving vitamin B1, B6, B12 or another vitamin supplemental therapy. * Receiving antidepressants, opioids, adjuvant analgesic agents (eg, anticonvulsants, clonazepam, or mexiletine), topical analgesics, and amifostine.
References
Publications (1)
- DERIVEDBakry HM, Mansour NO, ElKhodary TR, Soliman MM. Efficacy of metformin in prevention of paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled trial. Front Pharmacol. 2023 Jul 31;14:1181312. doi: 10.3389/fphar.2023.1181312. eCollection 2023. PMID 37583905