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

Ann Oncol. 2017 Aug 1;28(8):1957-1963. doi: 10.1093/annonc/mdx232.

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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Anorexia / drug therapy*
  • Anorexia / etiology
  • Creatine / pharmacology
  • Creatine / therapeutic use*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Neoplasms / complications*
  • Placebos
  • Weight Loss / drug effects*

Substances

  • Placebos
  • Creatine