Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 is a NA study that has completed, run by Texas A&M University. The registered enrollment target is 19 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 19 participants
Start Date 2009-08-18
Est. Completion 2012-02-04
Phase NA

Sponsor

Texas A&M University

95 total trials

What the Registry Record Tells You About NCT00497380

The ClinicalTrials.gov registry entry for NCT00497380 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Texas A&M University, which has 95 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Arginine is the first listed.

NCT00497380 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.