Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT00081250
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00081250
Study Brief:
Protocol Section:
NCT00081250