Purpose

Fifteen patients with advanced H&N cancer who will receive chemoradiation therapy as first line treatment will be studied (as weight loss is expected). The cancer patients will be recruited at the UT Health Mays Cancer Center (MCC) in San Antonio with testing to be performed at the Barshop Institute. The cancer group will be compared to 15 control subjects, recruited at CTRAL (Center for Translational Research on Aging and Longevity) in College Station, who are age/sex/BMI matched and with no active or historic cancer diagnosis based on extensive medical screening.

Category

IRB Number
STUDY00001164
NCT Number
-
Open to Enrollment
Yes
Sponsor
-



Study Contact

Principal Investigator
Sherri Cervantez

Regulatory Point of Contact
Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu

Regulatory Point of Contact
Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu

Regulatory Point of Contact
Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu

Regulatory Point of Contact
Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu

Regulatory Point of Contact
Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
-
Eligible Genders
all
Accepts Healthy Volunteers
No

Inclusion Criteria

    1. Locally Advanced (stage II, III and IV) H&N cancer patients including p16 negative and positive who are scheduled for chemoradiation as first line treatment for at least 6 weeks.
    2. Must be willing and able to provide written informed consent or have a legally authorized representative provide consent.
    3. Has an ECOG performance status of 0, 1, or 2 at screening.
    4. Adults ≥18 at the time the consent is signed.
    5. Is willing and able to participate in the collection of patient-reported outcome (PRO) data.
    6. English speaking and able to read and write in English.

Exclusion Criteria

    1. Untreated metabolic diseases, presence of acute illness or metabolically unstable chronic illness.
    2. Receiving anti-cancer treatment (surgery, chemotherapy and/or radiation therapy) in the month prior to screening
    3. Nasopharyngeal primary cancers or p16 negative unknown primary cancers
    4. History of another primary malignancy (beyond H&N) except for:
      1. Malignancy treated with curative intent and with no known active disease ≥3 years before the first assessment
      2. Adequately treated non-melanoma skin cancer, lentigo maligna, or lentigo maligna melanoma without evidence of disease
      3. Adequately treated carcinoma in situ without evidence of disease
    5. Patients with implanted cardiac devices (i.e. pacemakers, defibrillators), metal implants or pregnancy