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Mitochondrial Respiratory Function in Mammalian Skeletal Muscle

Sponsor
The University of Texas Medical Branch, Galveston (Other)
Overall Status
Terminated
CT.gov ID
NCT02650570
Collaborator
(none)
1
Enrollment
1
Location
1.4
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Mitochondrial Respiratory Function in Mammalian Skeletal Muscle: Metabolic Insights Into Cancer and Burn Cachexia Through Comparative Physiology of Humans and Marine Mammals
    Actual Study Start Date :
    Feb 14, 2017
    Actual Primary Completion Date :
    Mar 29, 2017
    Actual Study Completion Date :
    Mar 29, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Head/Neck Cancer

    Subjects diagnosed with advanced (stages III or IV), persistent (recurrence within 6 months) or recurrent head and neck squamous cell carcinoma (HNSCC)
    Healthy Control

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

    Outcome Measures

    Primary Outcome Measures

    1. Baseline skeletal muscle oxygen consumption (pmol O2/s*mg) in head and neck cancer patients and healthy age-matched controls [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.

    2. Skeletal muscle oxygen consumption (pmol O2/s*mg) in head and neck cancer patients following 4 weeks of standard of care. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Texas Medical Branch Galveston Texas United States 77555

    Sponsors and Collaborators

    • The University of Texas Medical Branch, Galveston

    Investigators

    • Principal Investigator: Melinda Sheffield-Moore, PhD, University of Texas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The University of Texas Medical Branch, Galveston
    ClinicalTrials.gov Identifier:
    NCT02650570
    Other Study ID Numbers:
    • 15-0056
    First Posted:
    Jan 8, 2016
    Last Update Posted:
    Oct 26, 2017
    Last Verified:
    Oct 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by The University of Texas Medical Branch, Galveston
    Cancer
    Cachexia
    Additional relevant MeSH terms:
    Wasting Syndrome
    Cachexia

    Study Results

    No Results Posted as of Oct 26, 2017