Clinical trial · Observational
Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase II
Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase 2
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| (non-radioactive) Oral deuterated 3-methylhistidine (D-3MH) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Newly Diagnosed NSCLC patients
- description
- In this study, newly diagnosed NSCLC patients who are not candidates for curative resection, will receive a (non-radioactive) oral dose of deuterated 3-methylhistidine (D-3MH).
- interventionNames
- Biological: (non-radioactive) Oral deuterated 3-methylhistidine (D-3MH)
Primary outcomes (1)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available