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Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston Identifier:
First received: October 13, 2009
Last updated: December 3, 2015
Last verified: December 2015
The long-term objective of this research is to develop a non-invasive approach for early assessment of which patients are at high risk for future development of skeletal muscle atrophy. The investigators hypothesize that the rate constant for the terminal portion of the isotope decay curve following ingestion of a single oral dose of deuterated-3-methylhistidine (D-3MH) provides an accurate measure of this increased risk and that this rate constant can be measured non-invasively from timed spot urine samples. In addition, the investigators hypothesize that ingestion of a meat-containing meal will stimulate synthesis of skeletal muscle proteins to a greater extent than a non-meat-containing meal.


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Assessment of the slope of terminal D-3MH/3MH decay curve post-dosing. [ Time Frame: Post-dosing 12 to 22 hours ]
    Assess the slope of the terminal D-3MH/3MH decay curve for the post-dosing time period as calculated using plasma or urine samples and after a meat-containing or meat-free test meal.

Enrollment: 17
Study Start Date: October 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
healthy control male
lung cancer male


Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community sample of healthy males and male lung cancer patients

Inclusion Criteria:

  • male
  • 30-85 years
  • Body Mass Index (BMI) <30 kg/m2

Exclusion Criteria:

  • Uncontrolled hypertension
  • Glomerular filtration rate less than 60 mL/min/1.73 m2
  • History of recurrent gastrointestinal bleeding
  • Unable or unwilling to provide informed consent
  • Ongoing anti-coagulant therapy
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Please refer to this study by its identifier: NCT00994669

United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
National Cancer Institute (NCI)
Principal Investigator: Melinda Sheffield-Moore, Ph.D. University of Texas
  More Information

Responsible Party: The University of Texas Medical Branch, Galveston Identifier: NCT00994669     History of Changes
Other Study ID Numbers: 09-150B
5R01CA127971 ( US NIH Grant/Contract Award Number )
Study First Received: October 13, 2009
Last Updated: December 3, 2015

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms processed this record on April 28, 2017