creatine in treating patients with cancer-associated weight loss

Conditions: Anorexia; Cachexia; Unspecified Adult Solid Tumor, Protocol Specific; Weight Changes

Summary: 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.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed cancer other than primary brain cancer * considered incurable with available therapies * 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 * 18 and over performance status * ecog 0-2 life expectancy * at least 3 months renal * creatinine normal cardiovascular * no poorly controlled congestive heart failure * no poorly controlled hypertension other * able to reliably receive oral medication * must be alert and mentally competent * no known obstruction of the alimentary tract, malabsorption, or intractable vomiting * no diabetes that is controlled by insulin * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: chemotherapy * concurrent chemotherapy allowed endocrine therapy * no other concurrent adrenal corticosteroids, androgens, or progestational agents within 30 days after study entry * concurrent short-term dexamethasone for chemotherapy-associated emesis is allowed * concurrent inhalant, topical, or optical steroids allowed radiotherapy * no concurrent radiotherapy to the bowel or stomach * other concurrent radiotherapy allowed other * no prior creatine use * no concurrent tube feedings or parenteral nutrition

Keywords: unspecified adult solid tumor, protocol specific cachexia anorexia weight changes