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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
300
Given orally
Given orally
Percentage of patients who gain weight over 1 month
Time frame: 1 month
Percentage of patients who manifest weight stability (i.e., weight within 5% of baseline) at 1 month
Time frame: 1 month
Percentage of patients who manifest stability in appetite
Time frame: Up to 5 years
Overall survival
Time frame: Up to 5 years
Incidence of treatment-related toxicity
Time frame: Up to 5 years
Quality of life
Time frame: Up to 5 years
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