Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss
RATIONALE: It is not yet known whether the supplement creatine is effective in increasing
weight and improving appetite and quality of life in patients who have cancer.
PURPOSE: This randomized phase III trial is studying how well creatine works in increasing
weight and improving appetite and quality of life in patients with weight loss caused by
cancer.
OBJECTIVES:
- Compare weight-gain effects of creatine vs placebo in patients with cancer-associated
weight loss and/or anorexia.
- Determine the effect of these regimens on quality of life in these patients.
- Compare the toxic effects of these regimens in these patients.
- Compare survival rates of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to primary cancer type (lung vs gastrointestinal vs other), weight loss
severity (< 10 lbs vs ≥10 lbs), age (< 50 years vs ≥ 50 years), planned concurrent
chemotherapy (yes vs no), gender, and prognosis. Patients are randomized to 1 of 2 treatment
arms.
- Arm I: Patients receive oral creatine daily.
- Arm II: Patients receive oral placebo daily. In both arms, treatment continues in the
absence of unacceptable toxicity as long as treatment is considered beneficial.
Patients are followed every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
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