Article

AIP: 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

Publish date: June 19, 2012

Patients perceive fatigue to be the most distressing symptom associated with their cancer experience, even worse than pain or nausea and vomiting. However, studies suggest that fatigue usually does not exist in isolation but rather as part of a symptom cluster that often includes depression, difficulty sleeping, and pain.
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  • Glenn J. Lesser, MD
    ,
  • Doug Case, PhD,
  • Nancy Stark, RN, PhD,
  • Susan Williford, MD,
  • Jeff Giguere, MD,
  • L. Astrid Garino, MD,
  • Michelle J. Naughton, PhD,
  • Mara Z. Vitolins, DrPH, RD,
  • Mark O. Lively, PhD,
  • Edward G. Shaw, MD, MA,
  • Wake Forest University Community Clinical Oncology Program Research Base

Abstract

Background

Coenzyme Q10 (CoQ10) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits.

Objectives

We performed a randomized, double-blind, placebo-controlled study of oral CoQ10 in female breast cancer patients with the primary objective of determining CoQ10's effects on self-reported fatigue, depression, and quality of life (QOL).

Methods

Eligible women with newly diagnosed breast cancer and planned adjuvant chemotherapy were randomized to oral supplements of 300 mg CoQ10 or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment was continued for 24 weeks. Blood tests, QOL measures, and levels of plasma CoQ10 and vitamin E were obtained at baseline and at 8, 16, and 24 weeks. Mixed-effects models were used to assess treatment differences in outcomes over time.

Results

Between September 2004 and March 2009, 236 women were enrolled. Treatment arms were well balanced with respect to age (range, 28−85 years), pathologic stage (stage 0, 91%; stage I, 8%; stage II, 1%), ethnicity (white, 87%; black, 11%; Hispanic, 2%), and planned therapy. Baseline CoQ10 levels in the CoQ10 and placebo arms were 0.70 and 0.73 μg/mL, respectively; the 24-week CoQ10 levels were 1.83 and 0.79 μg/mL, respectively. There were no significant differences between the CoQ10 and placebo arms at 24 weeks for scores on the Profile of Mood States–Fatigue questionnaire (least squares means, 7.08 vs 8.24, P = .257), the Functional Assessment of Chronic Illness Therapy–Fatigue tool (37.6 vs 37.6, P = .965), the Functional Assessment of Cancer Therapy–Breast Cancer instrument (111.9 vs 110.4, P = .577), or the Center for Epidemiologic Studies–Depression scale (11.6 vs 12.3, P = .632).

Conclusions

Supplementation with conventional doses of CoQ10 led to sustained increases in plasma CoQ10 levels but did not result in improved self-reported fatigue or QOL after 24 weeks of treatment.

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