Mitochondrial Respiratory Function in Mammalian Skeletal Muscle

NCT02650570 | Terminated

• 1 other identifier: 15-0056
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Cachexia

Keywords

Cancer; Cachexia

Outcome Measures

Primary Outcomes (2)

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

  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.

  Baseline

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

  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.

  4 weeks

Study Arms (2)

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.

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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.
• Pregnancy.
• Hyperprolactinoma, hypothyroidism.
• Granulocyte Count below 1.5x103/µL
• Platelet Count below 150 x 103/µL
• White Blood Cell Count below 1.0x103/µL
• Hemoglobin below 8.0 g/dL
• Organ transplant, HIV, or other criteria deemed immunosuppressing by the PI or study physician.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

The University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma will be collected and retained in the PI lab.

MeSH Terms

Conditions

Neoplasms; Cachexia

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Melinda Sheffield-Moore, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: January 8, 2016
• Study Start: February 14, 2017
• Primary Completion: March 29, 2017
• Study Completion: March 29, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)