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Clinical Trials/NCT02650570
NCT02650570
Terminated
Not Applicable

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

The University of Texas Medical Branch, Galveston1 site in 1 country1 target enrollmentFebruary 14, 2017
ConditionsCancerCachexia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
The University of Texas Medical Branch, Galveston
Enrollment
1
Locations
1
Primary Endpoint
Baseline skeletal muscle oxygen consumption (pmol O2/s*mg) in head and neck cancer patients and healthy age-matched controls
Status
Terminated
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 14, 2017
End Date
March 29, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Men and women, aged 30-60 years.
  • 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).
  • Healthy sex and age matched controls (n=10.)
  • Able to comprehend risks and sign a consent form.
  • Fluent in English

Exclusion Criteria

  • Significant renal or heart disease or any acute metabolic disease.
  • Evidence of hepatitis as indicated by a 3-fold increase in of 2 out of 3 liver enzymes.
  • Diabetes mellitus or other untreated endocrine disease.
  • Recent (within 3 months) treatment with anabolic steroids.
  • Ongoing anticoagulant therapy.
  • Polycystic ovary syndrome (PCOS) and/or hyperthecosis.
  • Non-classical adrenal hyperplasia.
  • Cushing's syndrome.
  • Hyperprolactinoma, hypothyroidism.
  • Granulocyte Count below 1.5x103/µL

Outcomes

Primary Outcomes

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.

Study Sites (1)

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