Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by The University of Texas, Galveston
Information provided by (Responsible Party):
The University of Texas, Galveston Identifier:
First received: October 13, 2009
Last updated: June 5, 2014
Last verified: June 2014

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, 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 ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 20
Study Start Date: October 2009
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
healthy control male
lung cancer male


Ages Eligible for Study:   30 Years to 85 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00994669

Contact: Kathleen Randolph, B.S. (409) 772-8126

United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas, Galveston
Principal Investigator: Melinda Sheffield-Moore, Ph.D. University of Texas
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston Identifier: NCT00994669     History of Changes
Other Study ID Numbers: 09-150B, 5R01CA127971
Study First Received: October 13, 2009
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board processed this record on March 03, 2015