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

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ClinicalTrials.gov Identifier: NCT00994669
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : December 4, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief Summary:
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.

Condition or disease
Cachexia

Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
Study Start Date : October 2009
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
U.S. FDA Resources

Group/Cohort
healthy control male
lung cancer male



Primary Outcome Measures :
  1. 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.



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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
Criteria

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

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): NCT00994669


Locations
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)
Investigators
Principal Investigator: Melinda Sheffield-Moore, Ph.D. University of Texas

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00994669     History of Changes
Other Study ID Numbers: 09-150B
5R01CA127971 ( U.S. NIH Grant/Contract )
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Cachexia
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms