Clinical Trial: Mitochondrial Respiratory Function in Mammalian Skeletal Muscle

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Mitochondrial Respiratory Function in Mammalian Skeletal Muscle: Metabolic Insights Into Cancer and Burn Cachexia Through Comparative Physiology of Humans and Marine Mammals

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 Summary:

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.

Current Primary Outcome:

• Baseline skeletal muscle oxygen consumption (pmol O2/s*mg) in head and neck cancer patients and healthy age-matched controls [ Time Frame: Baseline ]
  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.
• Skeletal muscle oxygen consumption (pmol O2/s*mg) in head and neck cancer patients following 4 weeks of standard of care. [ Time Frame: 4 weeks ]
  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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The University of Texas Medical Branch, Galveston

Dates:
Date Received: December 8, 2015
Date Started: December 2015
Date Completion: December 2016
Last Updated: December 8, 2016
Last Verified: August 2016