Clinical trial · Interventional
Trimetazidine Efficacy in Attenuating Paclitaxel-Induced Peripheral Neuropathy
Evaluation of Trimetazidine in Alleviating Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients
NCT06459193CI-TRIAL-00087856completedPhase 1 / Phase 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)
This proof-of-concept study evaluated the effect of Trimetazidine on the incidence of paclitaxel-induced peripheral neuropathy in patients with breast cancer.
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 |
|---|---|---|---|
| Peripheral Neuropathy Due to Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Trimetazidine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention
- description
- Trimetazidine Tablet 35 mg once daily for the treatment period
- interventionNames
- Drug: Trimetazidine
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- Placebo once daily for the treatment period
- interventionNames
- Drug: Placebo
Primary outcomes (2)
- measure
- Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria
- timeFrame
- weekly for up to 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer patients who will receive paclitaxel. * Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 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: * Patients with signs and symptoms of clinical neuropathy at baseline. * Patients with diabetes mellitus, alcoholic disease, heart failure, pregnant or lactating women. * Patients receiving vitamin/ supplementation drugs that interfere with the study intervention. * Patients with contraindications to trimetazidine including Parkinson's disease, Parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.
References
Publications (4)
- BACKGROUNDKhalefa HG, Shawki MA, Aboelhassan R, El Wakeel LM. Evaluation of the effect of N-acetylcysteine on the prevention and amelioration of paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled study. Breast Cancer Res Treat. 2020 Aug;183(1):117-125. doi: 10.1007/s10549-020-05762-8. Epub 2020 Jun 29. PMID 32601973
- BACKGROUNDHaroun EA, Mansour NO, Eltantawy A, Shams MEE. Effect of cilostazol on preventing paclitaxel-induced neuropathy in patients with breast cancer: A randomized controlled trial. Pharmacotherapy. 2023 Sep;43(9):872-882. doi: 10.1002/phar.2830. Epub 2023 Jun 12. PMID 37199288
- BACKGROUNDHammad ASA, Sayed-Ahmed MM, Abdel Hafez SMN, Ibrahim ARN, Khalifa MMA, El-Daly M. Trimetazidine alleviates paclitaxel-induced peripheral neuropathy through modulation of TLR4/p38/NF-kappaB and klotho protein expression. Chem Biol Interact. 2023 May 1;376:110446. doi: 10.1016/j.cbi.2023.110446. Epub 2023 Mar 9. PMID 36898573
- DERIVEDIqbal AN, Mady FM, Sadek EM, Abdullah NM, Abdel-Azeez AM, Shorog E, Wahsh EA. Evaluation of trimetazidine in alleviating paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled trial. Front Pharmacol. 2026 Feb 2;17:1748399. doi: 10.3389/fphar.2026.1748399. eCollection 2026. PMID 41704280