Status:
COMPLETED
Creatine in Treating Patients With Cancer-Associated Weight Loss
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anorexia
Cachexia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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 p...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2017
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00081250
Start Date
December 1 2004
End Date
July 1 2017
Last Update
April 29 2020
Active Locations (220)
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1
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
2
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
3
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
4
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019