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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02650570
Other study ID # 15-0056
Secondary ID
Status Terminated
Phase N/A
First received December 8, 2015
Last updated October 24, 2017
Start date February 14, 2017
Est. completion date March 29, 2017

Study information

Verified date October 2017
Source The University of Texas Medical Branch, Galveston
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date March 29, 2017
Est. primary completion date March 29, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States The University of Texas Medical Branch Galveston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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