Double-Blind, Placebo-Controlled Randomized Trial of Creatine for the Cancer Anorexia/Weight Loss Syndrome (N02C4): an Alliance Trial
Mené sur 263 patients atteints de cancer et souffrant d'une perte de poids ou d'une anorexie, cet essai randomisé évalue l'efficacité, du point de vue d'une prise de poids égale ou supérieure à 10 % pendant le premier mois de traitement, et la toxicité de la créatine, un dérivé d'acide aminé naturel
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 gram per day load x 5 days followed by 2 grams per day orally) versus identical placebo. Patients were weighed once a week for one month and then monthly. Patients were also assessed over one 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 one 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.