Coenzyme Q10 supplementation significantly reduced the incidence of grade ≥2 paclitaxel-induced peripheral neuropathy compared to control (68% vs 96%, OR 0.08).
RCT (n=60)
Open-label
Simple randomization using a computer-generated random sequence
No
Does oral Coenzyme Q10 reduce the cumulative incidence of grade ≥ 2 peripheral neuropathy in breast cancer patients receiving paclitaxel?
Coenzyme Q10 supplementation during paclitaxel therapy significantly reduces the incidence of clinically relevant peripheral neuropathy and preserves left ventricular ejection fraction in breast cancer patients.
Odds Ratio: 0.08 (95% CI 0.01–0.743)
Absolute Event Rate: 68% vs 96%
p-value: p=0.01
Abstract Background Paclitaxel is an effective chemotherapeutic agent for breast cancer, but its use is often limited by cumulative toxicities linked to mitochondrial dysfunction and oxidative stress. This study investigated whether Coenzyme Q10 (CoQ10) could mitigate paclitaxel-induced adverse events and improve treatment tolerability. Patients and methods In this open label randomized controlled trial, 60 patients with breast cancer were randomized (1:1) receive weekly paclitaxel (80 mg/m²) for 12 weeks either alone (control group, n = 30) or in combination with oral CoQ10. The primary outcome was the cumulative incidence of grade ≥ 2 peripheral neuropathy. Secondary endpoints included time-to-onset of grade ≥ 2 neuropathy; fatigue, headache, insomnia, musculoskeletal, gastrointestinal, and hematological adverse events; and left ventricular ejection fraction. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Results CoQ10 supplementation was associated with a lower incidence of clinically relevant neuropathy, with grade ≥ 2 events occurring in 68% of the CoQ10 group versus 96% of controls (p = 0.01) with delayed onset of neuropathy (30.0 vs. 20.0 days; log-rank p = 0.005). Significant reductions in severity were also observed for fatigue and insomnia from week 9, and for mucositis, diarrhea, arthralgia, and myalgia from week 11 (p < 0.05). Hemoglobin levels were higher at week 12 (p = 0.009). CoQ10 was associated with preservation of left ventricular ejection fraction (p = 0.005). Conclusion CoQ10 supplementation during paclitaxel therapy was associated with reduced treatment-related toxicities, preservation of hematologic parameters, and favorable changes in left ventricular ejection fraction, with favorable tolerability. Trial registration ClinicalTrials.gov (NCT06570811) on August 26, 2024. Available at: https://clinicaltrials.gov/study/NCT06570811 .
Hassoub et al. (Sat,) conducted a rct in Breast cancer (n=60). Coenzyme Q10 vs. Paclitaxel alone was evaluated on Cumulative incidence of grade ≥2 paclitaxel-induced peripheral neuropathy at week 12 (OR 0.08, 95% CI 0.010-0.743, p=0.01). Coenzyme Q10 supplementation significantly reduced the incidence of grade ≥2 paclitaxel-induced peripheral neuropathy compared to control (68% vs 96%, OR 0.08).
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