Cancer Clinical Trial
Official title:
Mitochondrial Respiratory Function in Mammalian Skeletal Muscle: Metabolic Insights Into Cancer and Burn Cachexia Through Comparative Physiology of Humans and Marine Mammals
Verified date | October 2017 |
Source | The University of Texas Medical Branch, Galveston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | March 29, 2017 |
Est. primary completion date | March 29, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 60 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Medical Branch | Galveston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Medical Branch, Galveston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Baseline skeletal muscle oxygen consumption (pmol O2/s*mg) in head and neck cancer patients and healthy age-matched controls | 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. | Baseline | |
Primary | Skeletal muscle oxygen consumption (pmol O2/s*mg) in head and neck cancer patients following 4 weeks of standard of care. | 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 after 4 weeks of standard of care (including chemotherapy, corticosteroids, etc. as prescribed by physician) will be compared to the average of their baseline measures. | 4 weeks |
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