- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01694602
Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase II (3MH-2)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Texas
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Galveston, Texas, United States, 77555-0361
- University of Texas Medical Branch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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).
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Oral dose of 9.0 mg (50 μmol) TAU-METHYL-L-HISTIDINE (METHYL-D3), Cambridge Isotope Laboratory, Cambridge, Massachusetts.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
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Spot urine (multiple) collections between 12 to 17 hours of D-3MH ingestion.
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Collaborators and Investigators
Investigators
- Principal Investigator: William J Durham, PhD, The University of Texas Medical Branch (UTMB Health), Galveston, Texas.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-064
- 2R44AR054993-02 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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