A double-blind, placebo-controlled randomized trial of creatine for the cancer anorexia/weight loss syndrome (N02C4): an Alliance trial

Abstract

Background: Multiple pilot studies, including one in colorectal cancer patients, suggest that creatine, an amino acid derivative, augments muscle, improves strength, and thereby could palliate the cancer anorexia/weight loss syndrome.

Patients and methods: In this randomized, double-blind, placebo-controlled trial, incurable patients with this syndrome were assigned creatine (20 g/day load×5 days followed by 2 g/day orally) versus identical placebo. Patients were weighed once a week for 1 month and then monthly. Patients were also assessed over 1 month for appetite and quality of life (validated questionnaires), fist grip strength, body composition (bioelectrical impedance), and adverse events. The primary endpoint was 10% or greater weight gain from baseline during the first month.

Results: Within this combined cohort of 263 evaluable patients (134 received creatine and 129 placebo), only 3 gained ≥10% of their baseline weight by 1 month: two creatine-treated and the other placebo-exposed (P = 1.00). Questionnaire data on appetite, quality of life, and activities of daily living showed no statistically significant differences between groups. Similarly, no statistically significant differences between groups were observed for fist-grip strength or body composition. Rates and severity of adverse events were comparable between groups. Finally, a median survival of 230 and 239 days were observed in the creatine and placebo groups, respectively (P = 0.70).

Conclusion: Creatine, as prescribed in this trial, had no effect on the cancer anorexia/weight loss syndrome.

Keywords: cachexia; creatine; nutrition; supportive care; weight loss.

Figure 1.

A total of 134 creatine-treated and 129 placebo-exposed patients were assessed for the primary endpoint.

Figure 2.

Over 1 month, only three patients gained ≥10% of their baseline weight: two in the creatine arm and the other in the placebo arm (P = 1.00). Over time, no trends emerged to indicate that creatine was effective.

Figure 3.

Median survival was 230 days versus 239 days in the creatine and placebo patients, respectively (P = 0.70 by log-rank test).