Mitochondrial Respiratory Function in Mammalian Skeletal Muscle
| Status: | Terminated |
|---|---|
| Conditions: | Cancer, Cancer, Other Indications |
| Therapuetic Areas: | Oncology, Other |
| Healthy: | No |
| Age Range: | 30 - 60 |
| Updated: | 10/28/2017 |
| Start Date: | February 14, 2017 |
| End Date: | March 29, 2017 |
Mitochondrial Respiratory Function in Mammalian Skeletal Muscle: Metabolic Insights Into Cancer and Burn Cachexia Through Comparative Physiology of Humans and Marine Mammals
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.
altered in patients with head and neck cancer compared to healthy controls.
20 men and women, 30-60 years, equally divided between patients diagnosed with advanced
(stages III or IV), persistent (recurrence within 6 months) or recurrent head and neck
squamous cell carcinoma (HNSCC) (n=10) and healthy age matched control subjects (n=10) will
be studied.
Muscle biopsies will be collected from cancer patients before and after a 4 week standard of
care (SOC) treatment. Muscle biopsies from healthy control subjects will be collected at
baseline only.
Lean body mass and fat mass will be determined by a DEXA scan before and after 4 week SOC
treatment (cancer patients) to document any change in body composition (cachexia), and at
baseline only in the age-matched healthy controls.
Blood will be collected from both cancer patients and healthy subjects to examine hormone
levels at the time of biopsy.
(stages III or IV), persistent (recurrence within 6 months) or recurrent head and neck
squamous cell carcinoma (HNSCC) (n=10) and healthy age matched control subjects (n=10) will
be studied.
Muscle biopsies will be collected from cancer patients before and after a 4 week standard of
care (SOC) treatment. Muscle biopsies from healthy control subjects will be collected at
baseline only.
Lean body mass and fat mass will be determined by a DEXA scan before and after 4 week SOC
treatment (cancer patients) to document any change in body composition (cachexia), and at
baseline only in the age-matched healthy controls.
Blood will be collected from both cancer patients and healthy subjects to examine hormone
levels at the time of biopsy.
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.
We found this trial at
1
site
301 University Blvd
Galveston, Texas 77555
Galveston, Texas 77555
(409) 772-1011
Principal Investigator: Melinda Sheffield-Moore, PhD
Phone: 409-772-8126
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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