Lesser, G. J., Case, D., Stark, N., Williford, S., Giguere, J., Garino, L. A., . . . Wake Forest University Community Clinical Oncology Program Research Base. (2013). A randomized, double-blind, placebo-controlled study of oral coenzyme Q(10) to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer. Journal of Supportive Oncology, 11, 31–42.

DOI Link

Study Purpose

To determine the effect of ​coenzyme Q10 (CoQ10) on self-reported fatigue, depression, and quality of life.

Intervention Characteristics/Basic Study Process

Patients were women with breast cancer and planned adjuvant chemotherapy randomized to oral supplements of 300 mg of CoQ10 or placebo, each combined with 300 IU of vitamin E in three daily doses. The intervention began within four days of starting chemotherapy and was continued for 24 weeks. All study assessments were conducted at baseline and 8,16, and 24 weeks. Serum CoQ10 and vitamin E levels were used to measure adherence to the study medications.

Sample Characteristics

  • The study included 175 patients with breast cancer (all women) who completed eight weeks and 139 patients who completed 24 weeks.  
  • Median age was 51 years (range 28–85).
  • Patients were newly diagnosed with breast cancer.

Setting

Patients' homes in South Carolina

Phase of Care and Clinical Applications

Patients were undergoing the active antitumor treatment phase of care.

Study Design

This was a randomized, placebo-controlled, double-blind trial.

Measurement Instruments/Methods

The study used multiple instruments with the primary outcome of fatigue:

  • Profile of Mood States-Fatigue (POMS-F)
  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
  • Linear analogue scale assessment [LASA]-Fatigue.

Results

No significant differences existed between the CoQ10 and placebo arms at 24 weeks for scores on the outcome instruments measuring fatigue. In addition, no significant differences were found on secondary outcomes, such as quality of life measured by the FACT-Brease Cancer (BC) instrument or the ​Center for Epidemiologic Studies Depression (CESD) Scale measuring depression.

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 quality of life after 24 weeks of treatment.

Nursing Implications

The study suggests that no evidence exists that using standard-dose CoQ10 supplementation to target fatigue in newly diagnosed women with breast cancer is effective in ameliorating treatment-related fatigue.