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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
  Purpose

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
Cachexia

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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
healthy control male
lung cancer male

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994669

Contacts
Contact: Kathleen Randolph, B.S. (409) 772-8126 kmrandol@utmb.edu

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

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00994669     History of Changes
Other Study ID Numbers: 09-150B, 5R01CA127971
Study First Received: October 13, 2009
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013