Clinical trial · Interventional
Coenzyme Q10 and Chemotherapeutic Toxicity in Breast Cancer Patients
Effect of Coenzyme Q10 (COQ10) on Chemotherapeutic Toxicity in Cancer Patients
NCT06570811CI-TRIAL-00099696completedPhase 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)
investigating the potential effect of Coenzyme Q10 in ameliorating and preventing the development of paclitaxel chemotherapeutic toxicity in breast 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 |
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Coenzyme Q10 200mg twice daily | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Placebo Comparator
- description
- Placebo Group: 20 patients will receive 80 mg/m2 of paclitaxel chemotherapy weekly for 12 weeks after receiving 4 cycles of AC protocol (Adriamycin and cyclophosphamide)
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Active Comparator
- description
- Coenzyme Q10 Group : 20 patients will receive paclitaxel weekly for 12 weeks after receiving 4 cycles of AC protocol (Adriamycin and cyclophosphamide) in addition to oral 200 mg Coenzyme Q10 twice daily for 3 months.
- interventionNames
- Drug: Coenzyme Q10 200mg twice daily
Primary outcomes (1)
- measure
- Number of Participants With Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. women with newly diagnosed breast cancer r ≥18 years old. 2. Naive to chemotherapy. 3. Eastern Cooperative Oncology Group (ECOG) performance status from 0-2 Exclusion Criteria: 1. Advanced liver disease (defined as liver enzyme elevation \>3-fold upper limit of normality, or cirrhosis); chronic kidney disease (CKD, defined as an estimated glomerular filtration rate (eGFR) \<60 ml min-1 1.73 m-2). 2. Patients with a history of allergy to Coenzyme Q10 and similar compounds. 3. Concomitant use of opioids, anticonvulsants, tricyclic antidepressants, other neuropathic pain medication. 4. Pregnancy or breast feeding. 5. hereditary muscle disorders.
References
Publications (5)
- 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
- BACKGROUNDBakry 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
- BACKGROUNDHernandez-Ojeda J, Cardona-Munoz EG, Roman-Pintos LM, Troyo-Sanroman R, Ortiz-Lazareno PC, Cardenas-Meza MA, Pascoe-Gonzalez S, Miranda-Diaz AG. The effect of ubiquinone in diabetic polyneuropathy: a randomized double-blind placebo-controlled study. J Diabetes Complications. 2012 Jul-Aug;26(4):352-8. doi: 10.1016/j.jdiacomp.2012.04.004. Epub 2012 May 16. PMID 22595020
- 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
- DERIVEDHassoub G, El-Bassiouny NA, Abdelkader Y, Badawy AA, Kassem AB. Coenzyme Q10 as an adjunctive strategy to reduce paclitaxel-induced toxicities in breast cancer: a randomized controlled trial. BMC Pharmacol Toxicol. 2026 Jul 4;27(1):95. doi: 10.1186/s40360-026-01163-7. PMID 42401951