Status:
COMPLETED
Effects of Nutritional Supplementation (Product 4808) on Acute Skeletal Muscle Protein Synthesis in Cancer Patients
Lead Sponsor:
University of Arkansas
Conditions:
Cancer
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The purpose of the study is to compare two different nutritional supplements with respect to their effect on building muscle, and to determine the factors that control the rate at which muscle tissue ...
Detailed Description
Muscle protein is generally diminished in cancer patients, with an effect on outcome. Research has shown that recurrence in treated patients is directly related to the extent of muscle loss. The effec...
Eligibility Criteria
Inclusion
- radiographic evidence of Cancer
- Ages 40 and older
- Ability to sign Informed Consent
Exclusion
- Patient received anti-cancer therapy or surgery less than 4 weeks prior to the experiment
- Body weight loss of more than 10% in past three months
- Body Mass Index less than 20kg/m2 or greater than 30 kg/m2
- Any documented autoimmune disease
- Peripheral vascular disease
- Hgb less than 9.0g/dL
- PT with INR greater than 1.5
- PTT greater than 40 seconds
- Platelet count less than 100,000
- Uncontrolled hypertension
- Currently using insulin to control high blood sugar
- Untreated metabolic diseases including liver or renal disease
- Currently in muscle strengthening program
- Use of supplements enriched with branched-chain amino acids
- History of hypo- or hyper-coagulation disorders, including patients taking Coumadin or history of deep venous thrombosis or pulmonary embolism at any point in their lifetime
- Currently taking aspirin and cannot stop for 7 days
- Presence of acute illness or metabolically unstable chronic illness
- Unstable heart disease requiring therapy or recent myocardial infarction (less than 1 year)
- Current alcohol or drug abuse
- Pregnancy or lactation (pre-menopausal women)
- Allergy/intolerance to any of the ingredients of the study products
- Any other condition deemed by the Principal Investigator and the study physician as exclusion or that interferes with proper study conduct or safety of the patient
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00446888
Start Date
January 1 2007
End Date
March 1 2009
Last Update
June 19 2009
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205