Clinical trial · Observational
Mitochondrial Respiratory Function in Mammalian Skeletal Muscle
Mitochondrial Respiratory Function in Mammalian Skeletal Muscle: Metabolic Insights Into Cancer and Burn Cachexia Through Comparative Physiology of Humans and Marine Mammals
NCT02650570CI-TRIAL-00030077terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding Ended
Summary
Brief summary (as posted)
The purpose of this study is to determine whether skeletal muscle mitochondrial function is altered in patients with head and neck cancer compared to healthy controls.
Conditions
Conditions (2)
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 | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Head/Neck Cancer
- description
- Subjects diagnosed with advanced (stages III or IV), persistent (recurrence within 6 months) or recurrent head and neck squamous cell carcinoma (HNSCC)
- label
- Healthy Control
- description
- Healthy controls age matched to the Head/Neck cancer group.
Primary outcomes (2)
- measure
- Baseline skeletal muscle oxygen consumption (pmol O2/s*mg) in head and neck cancer patients and healthy age-matched controls
- timeFrame
- Baseline
- description
- Aerobic respiration will be measured from skeletal muscle biopsies of the vastus lateralis using Oroboros O2K high resolution respirometry. The average maximal skeletal muscle oxygen consumption of 10 head and neck cancer subjects will be compared to the average of 10 healthy controls.
- measure
- Skeletal muscle oxygen consumption (pmol O2/s*mg) in head and neck cancer patients following 4 weeks of standard of care.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men and women, aged 30-60 years. 2. Diagnosed with advanced (stages III or IV), persistent (recurrence within 6 months) or recurrent head and neck squamous cell carcinoma (HNSCC) and being treated at UTMB (n=10). 3. Healthy sex and age matched controls (n=10.) 4. Able to comprehend risks and sign a consent form. 5. Fluent in English Exclusion Criteria: 1. Significant renal or heart disease or any acute metabolic disease. 2. Evidence of hepatitis as indicated by a 3-fold increase in of 2 out of 3 liver enzymes. 3. Diabetes mellitus or other untreated endocrine disease. 4. Recent (within 3 months) treatment with anabolic steroids. 5. Ongoing anticoagulant therapy. 6. Polycystic ovary syndrome (PCOS) and/or hyperthecosis. 7. Non-classical adrenal hyperplasia. 8. Cushing's syndrome. 9. Pregnancy. 10. Hyperprolactinoma, hypothyroidism. 11. Granulocyte Count below 1.5x103/µL 12. Platelet Count below 150 x 103/µL 13. White Blood Cell Count below 1.0x103/µL 14. Hemoglobin below 8.0 g/dL 15. Organ transplant, HIV, or other criteria deemed immunosuppressing by the PI or study physician. 16. Any other circumstance deemed exclusionary by the PI or study physician.
References
Publications (0)
Data not yet available
No reference posted for this study.