Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase II (3MH-2)
|ClinicalTrials.gov Identifier: NCT01694602|
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : July 2, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Cachexia||Biological: (non-radioactive) Oral deuterated 3-methylhistidine (D-3MH)||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.
|Study Type :||Observational|
|Actual Enrollment :||8 participants|
|Official Title:||Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase 2|
|Study Start Date :||November 2012|
|Primary Completion Date :||June 2015|
|Study Completion Date :||June 2015|
Newly Diagnosed NSCLC patients
In this study, newly diagnosed NSCLC patients who are not candidates for curative resection, will receive a (non-radioactive) oral dose of deuterated 3-methylhistidine (D-3MH).
Biological: (non-radioactive) Oral deuterated 3-methylhistidine (D-3MH)
Oral dose of 9.0 mg (50 μmol) TAU-METHYL-L-HISTIDINE (METHYL-D3), Cambridge Isotope Laboratory, Cambridge, Massachusetts.
- 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. ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694602
|United States, Texas|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555-0361|
|Principal Investigator:||William J Durham, PhD||The University of Texas Medical Branch (UTMB Health), Galveston, Texas.|