Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase 2
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.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
Determination of myofibrillar protein degradation rate constant and slope of terminal decay curve.
Spot urine (multiple) collections between 12 to 17 hours of D-3MH ingestion.
No
William J Durham, PhD
Principal Investigator
The University of Texas Medical Branch (UTMB Health), Galveston, Texas.
United States: Food and Drug Administration
12-064
NCT01694602
November 2012
June 2016
Name | Location |
---|---|
University of Texas Medical Branch | Galveston, Texas 77555-1329 |