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

Abstract

Background Coenzyme Q10 (CoQ10) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits. Objective 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, quality of life (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 to 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 μg/mL and 0.73 μg/mL, respectively; the 24-week CoQ10 levels were 1.83 μg/mL 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 (POMS-F) questionnaire (least squares means, 7.08 vs 8.24; P = .257), the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) tool (37.6 vs 37.6; P = .965), the Functional Assessment of Cancer Therapy–Breast Cancer (FACT-B) instrument (111.9 vs 110.4; P = .577), or the Center for Epidemiologic Studies–Depression (CES-D) 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.

Efficacy and safety of an amino acid jelly containing coenzyme Q10 and l-carnitine in controlling fatigue in breast cancer patients receiving chemotherapy: a multi-institutional, randomized, exploratory trial (JORTC-CAM01)

“…However, phase III, randomized, double-blind, placebocontrolled studies have demonstrated a lack of improvement in CRF in cancer patients receiving coenzyme Q10 (100 mg three times daily) and L-carnitine (1 g twice daily) supplements [39,40]. Considering that lower doses of coenzyme Q10 (30 mg) and L-carnitine (50 mg) were used in our study than in these previous studies, the combination of IP components including branched-chain amino acids most likely contributed to the improvement in CRF observed in our study.…”

Management of Fatigue Following Breast Cancer Treatment

“…This is a common antioxidant supplement with known cardio-protective effects and potential anticancer benefits. The first double blind, placebo-controlled study carried out in women with breast cancer submitted to adjuvant chemotherapy has recently been published [43]. Coenzyme Q 10 was used at doses of 100 mg three-times daily in combination with vitamin E (100 mg for each dose of coenzyme Q 10 ) for 24 weeks.…”

Coenzyme Q10 therapy in current clinical practice

“…1 Other side effects of CoQ 10 may include heartburn, elevated liver enzymes, insomnia, dizziness, irritability, headache and photophobia; however, regardless of the dosage used, few untoward effects have been observed. 2 CoQ 10 may increase the risk of bleeding due to its antiplatelet effect. It undergoes biotransformation in the liver and is eliminated via the biliary tract, so it gets accumulated in patients with biliary obstruction or hepatic impairment.…”

“…8 Literature suggested that at least 80% of cancer patients who are undergoing multimodality treatment, experience a significant degree of fatigue that may negatively impact their treatment tolerance, emotional well-being and quality of life (QOL). 2 Many clinical trials have addressed correlation between CoQ 10 and fatigue. …”

“…1 It is a lipid soluble substance which is found in cell membranes and is well known for its primary role as an intermediate of the electron transport chain localized in mitochondrial membranes and is vital for aerobic cellular respiration. 2 Adequate amounts of CoQ 10 are essential for ATP production and cellular respiration. CoQ 10 also acts as an intercellular antioxidant and is present in blood, cell membranes low density lipoproteins and high density lipoproteins.…”