Clinical Trial: Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase II
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase 2
Brief Summary:
The overall aim of this research is to develop a non-invasive approach to evaluate the production of 3-methylhistidine (3MH)in cancer patients, as a potential means of determining which patients are at high risk for future development of cancer induced skeletal muscle atrophy.
Rationale: The approach is based on the hypothesis that after an oral dose of deuterated 3-methylhistidine (D-3MH), the slope of the terminal portion of the decay curve (> 12 hours post-dosing) for the tracer/tracee (D-3MH/3MH) in the free 3MH pool is proportional to the rate constant for myofibrillar protein degradation and can be determined from spot urine samples.
Detailed Summary:
The long-term objective of this research is to develop a non-invasive approach for assessment of de novo 3MH production in cancer patients early in the course of the disease as a way of assessing which patients are at high risk for future development of skeletal muscle atrophy. The approach is based on: 1) the known increase in de novo production of 3-methylhistidine (3MH) from muscle protein breakdown in said patients as a consequence of their unique disease-host interactions, and 2) earlier demonstration that de novo 3MH production can be measured in vivo using isotope dilution.
During this Phase-II project, we propose to conduct a statistically powerful prospective investigation to demonstrate that measurement of the slope of the terminal decay curve (rate constant) with our approach in newly diagnosed cancer patients predicts future development of muscle wasting. We expect the outcome of the combined Phase-I and Phase-II research to lead to the early identification of elevated muscle catabolism in at-risk patients so that medical intervention can prevent future muscle atrophy.
Sponsor: The University of Texas Medical Branch, Galveston
Current Primary Outcome: Determination of myofibrillar protein degradation rate constant and slope of terminal decay curve. [ Time Frame: Spot urine (multiple) collections between 12 to 17 hours of D-3MH ingestion. ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: The University of Texas Medical Branch, Galveston
Dates:
Date Received: September 24, 2012
Date Started: November 2012
Date Completion:
Last Updated: July 1, 2015
Last Verified: July 2015
