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Arginine Feeding: a Novel Strategy to Improve Protein Metabolism in Cancer and the Response to Surgery


N/A
30 Years
N/A
Open (Enrolling)
Female
Protein Metabolism

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Trial Information

Arginine Feeding: a Novel Strategy to Improve Protein Metabolism in Cancer and the Response to Surgery


In the present proposal, the effects of surgery and cancer will be examined by comparing
subjects undergoing breast surgery because of malignancy vs. prophylactic reasons (aim 1).
Furthermore, the effects of one-week pre-operative protein feeding with or without
enrichment with arginine on post-operative protein metabolism (aim 2) will be investigated
in the cancer group. Variables of interest are: 1. Whole-body and skeletal muscle protein
metabolism, whole body arginine turnover and de-novo arginine production rate, and the
anabolic capacity to feeding(assessed by stable isotope methodology). 2. Body weight, muscle
mass and functional status, score for well-being (assessed by Profile of Mood State and Mini
Mental State).

In the present study, we propose that a nutritional supplement that is high in protein
content and enhanced in arginine will be more effective than a typical commercial
nutritional supplement in diminishing the catabolic effects of surgery in subjects with
cancer, thereby optimizing their quality of life. If this is found to be the case, this
would provide the basis for reformulating the nutritional composition in accord with the
effects of cancer and surgery on protein metabolism.


Inclusion Criteria:



Cancer groups (for aims 1 and 2)

1. Recently diagnosed (up to 4 weeks prior to treatment for cancer) with stage I, II
or III invasive breast cancer

2. Undergoing mastectomy

3. Age greater than 30 years

4. Ability to sign informed consent

5. Good performance status defined by ECOG scale 0,1 or 2 (see CRF performance status)

Control group (for aim 1)

1. Age greater than 30 years

2. Undergoing prophylactic mastectomy

3. Ability to sign informed consent

4. Good performance status defined by ECOG scale 0,1 or 2 (see CRF performance status)

Exclusion Criteria:

All groups (aim 1 and 2)

1. Body weight loss of greater than 10% in the past 3 months

2. Previous anti-cancer therapy (e.g. chemotherapy or radiotherapy) or surgery less than
4 weeks prior to the experiment

3. Diagnosed diabetes type I or II

4. Untreated metabolic diseases including liver or renal disease

5. Any documented autoimmune disease

6. Use of corticosteroids, beta-antagonists or nitrovasodilators

7. Use of supplements enriched with amino acids

8. Presence of acute illness or metabolically unstable chronic illness

9. Unstable heart disease requiring therapy or recent myocardial infarction (less than 1
year)

10. Current alcohol or drug abuse (ETOH more than 2 servings per day)

11. Allergy/intolerance to any of the ingredients of the study products

12. Any other condition deemed by the PI and the study physician as exclusion or that
interferes with proper conduct of the study/ safety of the patient.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Outcome Measure:

Net protein balance

Outcome Time Frame:

end of study

Safety Issue:

No

Principal Investigator

Nicolaas Deutz, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas

Authority:

United States: Institutional Review Board

Study ID:

81167

NCT ID:

NCT00497380

Start Date:

April 2009

Completion Date:

December 2014

Related Keywords:

  • Protein Metabolism

Name

Location
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205