Coenzyme Q10 as an adjunctive strategy to reduce paclitaxel-induced toxicities in breast cancer: a randomized controlled trial
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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