Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss
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:
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.
Patients are followed every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed cancer other than primary brain cancer
History of weight loss ≥ 5 lbs in 2 months or fewer AND/OR estimated intake of < 20 cal/kg daily
Determination by attending physician that weight gain would benefit patient
Perception by patient that weight loss is a problem
No symptomatic or untreated brain metastases
No clinical evidence of ascites
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Endocrine therapy
Radiotherapy
Other
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