Clinical trial NCT02650570: Mitochondrial Respiratory Function in Mammalian Skeletal Muscle
Official title: Mitochondrial Respiratory Function in Mammalian Skeletal Muscle: Metabolic Insights Into Cancer and Burn Cachexia Through Comparative Physiology of Humans and Marine Mammals
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Cachexia
Keywords: Cancer
Cachexia
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 1
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects diagnosed with advanced (stages III or IV), persistent (recurrence within 6 months) or recurrent head and neck squamous cell carcinoma (HNSCC) (n=10).

Healthy Controls (n=10).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Baseline skeletal muscle oxygen consumption (pmol O2/s*mg) in head and neck cancer patients and healthy age-matched controls
timeFrame: Baseline
measure: Skeletal muscle oxygen consumption (pmol O2/s*mg) in head and neck cancer patients following 4 weeks of standard of care.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Melinda Sheffield-Moore, PhD
role: PRINCIPAL_INVESTIGATOR
References: