Bruera, E., Strasser, F., Palmer, J.L., Willey, J., Calder, K., Amyotte, G., & Baracos, V. (2003). Effect of fish oil on appetite and other symptoms in patients with advanced cancer and anorexia/cachexia: A double-blind, placebo-controlled study. Journal of Clinical Oncology, 21, 129–134.

To evaluate the efficacy of 1,000 mg fish oil capsules versus placebo of 1,000 mg olive oil capsules in a two-arm trial

A daily dose of 18 capsules was given over a two-week period. Dosage decreased to a minimum of six capsules daily secondary to intolerance. Mean eicosapentaenoic acid (EPA) dose was 1.8 g/day. Docosahexaenoic acid dose was 1.2 g/day.

• Eligibility requirements were presence of anorexia (> 3 on visual analog scale) plus weight loss (> 5% pre-illness weight), ability to maintain oral food intake over the course of study, normal cognition (using Mini-Mental State Score), written informed consent, and advanced cancer (locally recurrent or metastatic disease).
• Sample size was 91 patients at outset, then randomized to 45 for study and 46 for placebo. After attrition, 30 patients for both groups completed the study.

The two-site trial was conducted in the Acute Palliative Care Unit at Grey Nuns Hospital and the inpatient and outpatient areas at Cross Cancer Institute in Edmonton, Alberta, Canada.

A randomized, placebo-controlled, double-blinded trial design was used.

• Visual analog scale (VAS) used to measure appetite, nausea, tiredness, and well-being
• Anthropometric measures of height, weight, body composition, muscular circumference, and skinfolds done in the office on days 1 and 14
• Functional level measured with Karnofsky Performance Status Scale and the Edmonton Functional Assessment Tool
• Plasma phospholipids
• Nutritional intake diary

Five patients in each group left the study secondary to gastrointestinal intolerance. There was no significant difference in any of the subjective or objective parameters between the two groups. Both groups showed an equal trend toward improved appetite, –9.8 for the fish oil and –9.0 for the olive oil placebo on the VAS.

• Length of study was limited to two weeks. Period was based on previous megestrol acetate trial results and perceived need for short-term symptomatic amelioration.
• Original study design was altered secondary to gastrointestinal intolerance: 18 capsules down to a minimum of 6 capsules per day. There was variance in actual amounts taken.
• High attrition rate of 31% brings into question whether the original sample size was large enough and if the ultimate results were underpowered.
• Whether the lack of significant findings was due to a reduced dose of fish oil or because of the short duration of study is questionable.