Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase II



Status:Completed
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2012
End Date:June 2015

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Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase 2

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.

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.

Inclusion Criteria:

- (1) histological or cytological evidence of NSCLC without curative options;

- (2) over 18 years of age;

- (3) patient reported weight loss of ≤5% of usual body weight in the last 6 months;

- (4) life expectancy of greater than 6 months based on the judgement of treating
physician;

- (5) serum creatinine ≤1.5 times the upper limit of normal; and

- (6) willing and able to give informed consent.

Exclusion Criteria:

- 1) malabsorption, intractable vomiting or gastrointestinal obstruction

- 2) congestive heart failure

- 3) edema or ascites

- 4) liver function test results that will preclude administration of prescribed
therapy

- 5) pregnant, nursing, or, if of child-bearing age, unwilling to use contraceptives
We found this trial at
1
site
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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from
Galveston, TX
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