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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 Cachexia Studies:
1. A Study of Different Doses of Megestrol Acetate in Patients with AIDS Who Have Anorexia and Malnutrition
2. Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer
3. Creatine in Treating Patients With Cancer-Associated Weight Loss
4. Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer
5. Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/day, and Placebo in AIDS Patients With Anorexia and Cachexia
Related Studies:
Other Cachexia Clinical Trials
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Creatine in Treating Patients With Cancer-Associated Weight Loss
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