Read, J. A., Beale, P. J., Volker, D. H., Smith, N., Childs, A., & Clarke, S. J. (2007). Nutrition intervention using an eicosapentaenoic acid (EPA)-containing supplement in patients with advanced colorectal cancer. Effects on nutritional and inflammatory status: a phase II trial. Supportive Care in Cancer, 15, 301–307.

DOI Link

Intervention Characteristics/Basic Study Process

An energy-dense oral nutritional supplement of eicosapentaenoic acid (EPA-ONS), an anti-inflammatory agent, was shown to reduce weight loss, increase lean body mass, and improve functional capacity and nutritional status in previous research. The EPA intervention instructed patients to consume two tetrapaks (480 mL) of EPA-ONS per day in addition to their regular diet for a total of nine weeks. Tetrapacks contained 16 g of protein, 1.09 g of EPA, and 0.46 g of docosahexaenoic acid (DHA). Chemotherapy commenced at week 4 and was repeated every two weeks. Patient outcomes were assessed at baseline, the end of week 3, and the end of week 9.

Sample Characteristics

  • The study was comprised of 23 patients with advanced colorectal cancer (CRC) who had one prior chemotherapy regimen (median age = 61 years).
  • The majority of the patients was male (n = 15) and had received previous surgery and chemotherapy (n = 17). 
  • Patients were excluded if they had previously received irinotecan, had preexisting intestinal disease, psychiatric disorders, edema, dehydration, or were unable to orally intake medications. Patients who could not have a three-week delay in administering cytotoxic chemotherapy without impacting disease progression were also excluded.

Setting

The study was conducted at the Royal Prince Alfred and Concord Hospitals in Sydney, Australia.

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was an open-label, phase II study.

Measurement Instruments/Methods

Disease and treatment assessment (DATA) form

Results

The EPA intervention resulted in a trend toward improvement during the full course of therapy for overall well-being (p = 0.05) and energy (p = 0.03). The quality of life measure for fatigue was maintained at the same mean score throughout the study.

Limitations

  • The study had a small sample size.
  • The study lacked a neutral comparison group.