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

This study is currently recruiting participants.
Verified April 2013 by The University of Texas, Galveston
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00994669
First received: October 13, 2009
Last updated: April 1, 2013
Last verified: April 2013
History of Changes

October 13, 2009
April 1, 2013
October 2009
December 2014   (final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00994669 on ClinicalTrials.gov Archive Site
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Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients

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.
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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

community sample of healthy males and male lung cancer patients
Cachexia
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  • healthy control male
  • lung cancer male
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
June 2015
December 2014   (final data collection date for primary outcome measure)

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
Male
30 Years to 85 Years
Yes
Contact: Kathleen Randolph, B.S. (409) 772-8126 kmrandol@utmb.edu
United States
 
NCT00994669
09-150B, 5R01CA127971
No
The University of Texas, Galveston
The University of Texas, Galveston
Not Provided
Principal Investigator: Melinda Sheffield-Moore, Ph.D. University of Texas
The University of Texas, Galveston
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP