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

Cachexia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00994669
• Other study ID #: 09-150B
• Secondary ID: 5R01CA127971
• Status: Completed
• Phase: N/A
• First received: October 13, 2009
• Last updated: December 3, 2015
• Start date: October 2009
• Est. completion date: October 2012

Study information

• Verified date: December 2015
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cachexia

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the slope of terminal D-3MH/3MH decay curve post-dosing.	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.	Post-dosing 12 to 22 hours	No