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NCT00497380 · ClinicalTrials.gov registry record · NA
Arginine Feeding: a Novel Strategy to Improve Protein Metabolism in Cancer and the Response to Surgery
A NA study, sponsored by Texas A&M University.
- Completed
- Registry status
- NA
- Development phase
- 19
- Enrollment target
NCT00497380: Completed NA study, sponsored by Texas A&M University.
NCT00497380 is a NA study that has completed, run by Texas A&M University. The registered enrollment target is 19 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00497380, a NA study, has completed, sponsored by Texas A&M University.
- COMPLETED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
Study Summary
Muscle catabolism is a major problem in cancer patients undergoing surgery as it negatively affects post-operative recovery. Recent evidence exists that protein metabolic changes are already apparent in cancer before muscle wasting is being present. In line, patients with breast cancer, generally characterized by a normal nutritional status, were recently found to be arginine deficient. Arginine deficiency in cancer can be explained by: 1) Reduced arginine availability, due to exhaustion of endogenous (muscle) sources of arginine 2) Enhanced arginine catabolism, due to conversion of arginine by arginase, which is abundant in tumors. Protein is the most important endogenous source of arginine. Arginine deficiency will lead to a negative feedback loop in cachexia by promoting protein breakdown in an attempt to restore plasma arginine levels. We hypothesize that pre-operative arginine supplementation in breast cancer patients diminishes the occurrence of muscle wasting after surgery by 1) normalizing arginine availability pre-operatively, resulting in conservation of protein, 2) diminishing the catabolic effects of surgery by supplying exogenous arginine for the post-operative response, 3) enhancing the anabolic capacity to feeding through supplying substrate for protein synthesis.
Interventions
- DIETARY_SUPPLEMENT Arginine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2009-08-18 |
| Est. Completion | 2012-02-04 |
| Phase | NA |
What the finished NCT00497380 record still lists
NCT00497380 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Arginine is the first listed.
NCT00497380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00497380 about?
NCT00497380 is a clinical study titled "Arginine Feeding: a Novel Strategy to Improve Protein Metabolism in Cancer and the Response to Surgery". Muscle catabolism is a major problem in cancer patients undergoing surgery as it negatively affects post-operative recovery. Recent evidence exists that protein metabolic changes are already apparent in cancer before muscle wasting is being present. In line, patients with breast cancer, generally ch...
What is the current status of trial NCT00497380?
This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2009-08-18. Estimated completion is 2012-02-04.
What interventions are being tested in trial NCT00497380?
The interventions under investigation include: Arginine (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00497380?
This trial is sponsored by Texas A&M University, which has 95 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00497380's enrollment target sits among peer trials
19 1861st of 2000 higher than 138 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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