Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase II (NCT01694602) | Clinical Trial Compass
CompletedNot Applicable
Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase II
United States8 participantsStarted 2012-11
Plain-language summary
The overall aim of this research is to develop a non-invasive approach to evaluate the production of 3-methylhistidine (3MH)in cancer patients, as a potential means of determining which patients are at high risk for future development of cancer induced skeletal muscle atrophy.
Rationale: The approach is based on the hypothesis that after an oral dose of deuterated 3-methylhistidine (D-3MH), the slope of the terminal portion of the decay curve (\> 12 hours post-dosing) for the tracer/tracee (D-3MH/3MH) in the free 3MH pool is proportional to the rate constant for myofibrillar protein degradation and can be determined from spot urine samples.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* (1) histological or cytological evidence of NSCLC without curative options;
* (2) over 18 years of age;
* (3) patient reported weight loss of ≤5% of usual body weight in the last 6 months;
* (4) life expectancy of greater than 6 months based on the judgement of treating physician;
* (5) serum creatinine ≤1.5 times the upper limit of normal; and
* (6) willing and able to give informed consent.
Exclusion Criteria:
* 1\) malabsorption, intractable vomiting or gastrointestinal obstruction
* 2\) congestive heart failure
* 3\) edema or ascites
* 4\) liver function test results that will preclude administration of prescribed therapy
* 5\) pregnant, nursing, or, if of child-bearing age, unwilling to use contraceptives
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determination of myofibrillar protein degradation rate constant and slope of terminal decay curve.
Timeframe: Spot urine (multiple) collections between 12 to 17 hours of D-3MH ingestion.
Trial details
NCT IDNCT01694602
SponsorThe University of Texas Medical Branch, Galveston