CachexiaNCT00994669
Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
An observational study of Cachexia, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cachexia
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample of healthy males and male lung cancer patients
Who may be able to join
- male
- 30-85 years
- Body Mass Index (BMI) <30 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
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.
- Conditions
- Cachexia
- Medical subject headings
- Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy control male | Not described | |
| lung cancer male | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-dosing 12 to 22 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Melinda Sheffield-Moore, Ph.D., Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994669
- Sponsor's protocol ID
- 09-150B
- Other IDs
- 5R01CA127971
- Status last verified
- Dec 2015
- First submitted
- 13 Oct 2009
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
- ClinicalTrials.gov ID
- NCT00994669
- Acronym / sponsor ID
- 09-150B
- Conditions
- Cachexia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy control male | – | – |
| lung cancer male | – | – |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample of healthy males and male lung cancer patients
Key inclusion criteria (3 listed)
- male
- 30-85 years
- Body Mass Index (BMI) <30 kg/m2
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melinda Sheffield-Moore, Ph.D. principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cachexia, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the slope of terminal D-3MH/3MH decay curve post-dosing. (time frame: Post-dosing 12 to 22 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2015.