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Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase II (3MH-2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01694602
First Posted: September 27, 2012
Last Update Posted: July 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
  Purpose

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 Intervention Phase
Cachexia Biological: (non-radioactive) Oral deuterated 3-methylhistidine (D-3MH) Phase 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase 2

Further study details as provided by The University of Texas Medical Branch, Galveston:

Primary Outcome Measures:
  • 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
Spot urine samples.

Enrollment: 8
Study Start Date: November 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will conduct a longitudinal study (repeated measures design) in 30 newly diagnosed nonsmall cell lung cancer (NSCLC) patients who are not candidates for curative resection.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694602


Locations
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0361
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
Principal Investigator: William J Durham, PhD The University of Texas Medical Branch (UTMB Health), Galveston, Texas.
  More Information

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT01694602     History of Changes
Other Study ID Numbers: 12-064
2R44AR054993-02 ( U.S. NIH Grant/Contract )
First Submitted: September 24, 2012
First Posted: September 27, 2012
Last Update Posted: July 2, 2015
Last Verified: July 2015

Keywords provided by The University of Texas Medical Branch, Galveston:
Cachexia
Sarcopenia
De Novo
Deuterated

Additional relevant MeSH terms:
Cachexia
Wasting Syndrome
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders