Mitochondrial Respiratory Function in Mammalian Skeletal Muscle

The University of Texas System (UT)

Status: Terminated

Conditions: Cachexia; Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02650570

15-0056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1 participants in 2 patient groups

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)

Healthy Control

Description:

Healthy controls age matched to the Head/Neck cancer group.