Creatine in Treating Patients With Cancer-Associated Weight Loss (NCT00081250) | Clinical Trial Compass
CompletedPhase 3
Creatine in Treating Patients With Cancer-Associated Weight Loss
United States300 participantsStarted 2004-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
What they're measuring
1
Percentage of patients who gain weight over 1 month