Anorexia, Cachexia, Unspecified Adult Solid Tumor, Protocol Specific, Weight Changes
Conditions
Keywords
unspecified adult solid tumor, protocol specific, cachexia, anorexia, weight changes
Brief 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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTcreatine monohydrate
Given orally
OTHERplacebo
Given orally
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients who gain weight over 1 month | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients who manifest weight stability (i.e., weight within 5% of baseline) at 1 month | 1 month |
| Percentage of patients who manifest stability in appetite | Up to 5 years |
| Overall survival | Up to 5 years |
| Incidence of treatment-related toxicity | Up to 5 years |
| Quality of life | Up to 5 years |
Countries
United States
Outcome results
None listed