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A randomized, double-blind, placebo-controlled study of oral coenzyme Q10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer

Glenn J Lesser, Doug Case, Nancy Stark, Susan Williford, Jeff Giguere, L Astrid Garino, Michelle J Naughton, Mara Z Vitolins, Mark O Lively, Edward G Shaw, Wake Forest University Community Clinical Oncology Program Research Base
Journal of Supportive Oncology 2013 11(1):31-42

Bibliography

PubMed
PMID 22682875
PubMed Central
PMC3501550
DOI
10.1016/j.suponc.2012.03.003
Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Supported by the National Cancer Institute Division of Cancer Prevention Grant U10 CA81851 to the Wake Forest University Community Clinical Oncology Program Research Base.
Competing interests
All authors submitted ICMJE disclosures. Dr Edward G. Shaw reported compensation for medicolegal expert testimony and payment for visiting-professor lectures; no CoQ10-product commercial conflict was reported.

Study snapshot

DesignRandomized, double-blind, placebo-controlled parallel trial; stratified by anthracycline chemotherapy and radiation; ClinicalTrials.gov lists quadruple masking.
ModelWomen with newly diagnosed breast cancer starting planned adjuvant chemotherapy, with or without radiation.
Sample236 randomized: 122 CoQ10+vitamin E and 114 placebo+vitamin E. Registry reports 78 and 61 completing the full study, respectively.
InterventionCoQ10 300 mg/day (Soft Gel Technologies; 100 mg three times daily) plus vitamin E 300 IU/day versus placebo plus the same vitamin E 300 IU/day, taken with food.
Duration24 weeks; assessments at baseline and weeks 8, 16 and 24.
EndpointsPrimary: POMS-Fatigue; FACIT-Fatigue; LASA-Fatigue; FACT-B quality of life; CES-D depression; Plasma CoQ10; Adverse events and discontinuation

What the study showed, in plain terms

This 236-woman randomized trial tested whether 300 mg/day of CoQ10 could prevent or reduce treatment-related fatigue during adjuvant breast-cancer therapy. Both groups also received 300 IU/day vitamin E, which served as a lipid carrier, so randomization isolates the added effect of CoQ10.

The supplement clearly changed exposure: mean plasma CoQ10 rose from 0.70 to 1.83 µg/mL by week 24 in the active arm, compared with 0.73 to 0.79 µg/mL in placebo. Despite that biochemical response, none of the main symptom or quality-of-life measures improved significantly.

At 24 weeks, POMS-F least-squares means were 7.08 versus 8.24 (p=0.257), FACIT-F 37.6 versus 37.6 (p=0.965), FACT-B 111.9 versus 110.4 (p=0.577), and CES-D 11.6 versus 12.3 (p=0.632). ClinicalTrials.gov reports 78/122 active and 61/114 control participants completed the full study; adverse-event discontinuations were 11 versus 9. No serious safety signal was highlighted in the published report.

This is therefore strong counterevidence to a broad claim that raising blood CoQ10 reliably relieves chemotherapy-related fatigue. It does not rule out effects in other fatigue syndromes or at other doses.

Key findings

  • Plasma CoQ10: 0.70 µg/mL baseline to 1.83 at 24 weeks active vs 0.73 to 0.79 placebo.
  • POMS-F at 24 weeks: LS mean 7.08 vs 8.24; p=0.257.
  • FACIT-F: 37.6 vs 37.6; p=0.965.
  • FACT-B: 111.9 vs 110.4; p=0.577.
  • CES-D: 11.6 vs 12.3; p=0.632.
  • Registry participant flow: 122 started active / 114 control; 78 / 61 completed. Adverse-event discontinuations: 11 active vs 9 control.

What this study can and cannot tell us

  • Substantial attrition: only 139/236 registry participants completed the overall study, although mixed-effects modeling can use repeated measurements before dropout.
  • Participants began with relatively low fatigue, potentially limiting room to demonstrate symptom improvement.
  • Both arms received vitamin E, so the study estimates the incremental effect of CoQ10 on top of vitamin E rather than CoQ10 versus an inert capsule alone.
  • Findings are specific to women with newly diagnosed breast cancer undergoing adjuvant therapy and should not be generalized to all fatigue conditions.
  • Biochemical exposure increased substantially without clinical symptom benefit, emphasizing that plasma-CoQ10 response is not a surrogate for fatigue efficacy.

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