Iwase, S., Kawaguchi, T., Yotsumoto, D., Doi, T., Miyara, K., Odagiri, H., . . . Yamaguchi, T. (2016). 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). Supportive Care in Cancer, 24, 637–646. 

DOI Link

Study Purpose

To investigate the effectiveness of a dietary supplement amino acid jelly containing coenzyme Q10 and L-carnitine in controlling fatigue in patients with breast cancer

Intervention Characteristics/Basic Study Process

A dietary supplement containing branched chain amino acids coenzyme Q10 and L-carnitine was given orally once daily for 21 days at a dose of 125 g. Patients in the control group received usual care. Study assessments were conducted on day 1 and day 22, and fatigue was measured on days 8 and 15.

Sample Characteristics

  • N = 57  
  • MEDIAN AGE = 50 years
  • AGE RANGE = 22–70 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All patients had breast cancer; 89% had recurrence, and 86% had metastases. All were receiving chemotherapy, with varied regimens.

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Not specified    
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Open-label, multicenter, randomized, controlled trial

Measurement Instruments/Methods

  • Brief Fatigue Inventory (BFI)
  • Hospital Anxiety and Depression Scale (HADS)
  • European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-C30)
  • EORTC QLQ-BR-23

Results

Fatigue initially increased from baseline to day 8 and then declined in both groups. The mean change in worst level of fatigue was greater with the intervention (p = 0.005). The mean reduction in current level of fatigue was greater with the intervention (p = 0.0009). No differences existed between groups in average feeling of fatigue or anxiety and depression scores.

Conclusions

The dietary supplement tested here may have some benefit in controlling fatigue among patients with breast cancer during chemotherapy.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • The study was underpowered.
  • No placebo control
  • Baseline fatigue levels were not reported, so whether baseline fatigue was clinically relevant is unknown.

Nursing Implications

These findings suggest that a dietary supplement of branched chain amino acids coenzyme Q10 and L-carnitine may be helpful for the management of fatigue. Further research is needed to confirm this potential.