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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cachexia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy control male

No interventions assigned to this group

lung cancer male

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melinda Sheffield-Moore, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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University of Texas Medical Branch

Galveston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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5R01CA127971

Identifier Type: NIH

Identifier Source: secondary_id

View Link

09-150B

Identifier Type: -

Identifier Source: org_study_id