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Home > "C" Clinical Trials Conditions > Creatine in Treating Patients With Cancer-Associated Weight Loss  Creatine in Treating Patients With Cancer-Associated Weight Loss
Creatine in Treating Patients With Cancer-Associated Weight Loss
For Condition: unspecified adult solid tumor, protocol specific,Cachexia,weight changes,Anorexia
Status: Not yet recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase III trial to determine the effectiveness of creatine in increasing weight and improving appetite and quality of life in patients who have weight loss caused by cancer.
Details: 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 274 patients (137 per arm) will be accrued for this study within approximately 19 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 Hematopoietic - Not specified Hepatic - Not specified Renal - Creatinine 1.5 times upper limit of 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: Biologic therapy - Not specified 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 Surgery - Not specified Other - No prior creatine use - No concurrent tube feedings or parenteral nutrition
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AminahJatoi, Study Chair, Mayo Clinic Cancer Center
Additional Information:
Study ID Numbers: CDR0000360798; NCCTG-N02C4
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081250
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/day, and Placebo in AIDS Patients With Anorexia and Cachexia
2. Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss
3. Creatine in Treating Patients With Cancer-Associated Weight Loss
4. Study to treat Cancer-Related Cachexia in Patients with Pancreatic Cancer
5. A Study of Different Doses of Megestrol Acetate in Patients with AIDS Who Have Anorexia and Malnutrition
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Creatine in Treating Patients With Cancer-Associated Weight Loss
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