Multifrequency Bioelectrical Impedance Analysis to Estimate Body Composition

Study Visits:

At the start of radiation therapy and then every week during treatment (about 6-7 weeks):

- You will have your weight and body mass measured with the mBCA. You will stand on a
scale with your feet on specific spots and your hands gripping the railing on either
side of you. There are electrodes in the hand grips and scale that will use very small
electrical currents to measure the water, muscle, and fat in your body. To do this test
you will need to hold still while standing for up to 50 seconds.

- You will have a physical exam.

- You will have a computed tomography (CT) or positron emission tomography (PET) scan to
check the status of the disease.

- You will complete the questionnaire about your symptoms.

Length of Study:

Your participation in this study will be over after you have completed follow-up.

Follow-Up:

About 10-12 weeks after you have completed radiation therapy:

- You will have your weight and body mass measured with the mBCA.

- You will have a physical exam.

- You will have a CT or PET scan.

- You will complete the questionnaire about your symptoms.

- Family members may be contacted for follow up data collection if you cannot be reached.

Other Information:

The information learned in this study will not affect your care or treatment.

Data collection will occur only during scheduled pre-treatment, treatment, and follow-up
visits. There will be no additional study visits required.

This is an investigational study. The mBCA is FDA approved for the use of measuring muscle
mass and hydration in healthy adults. Its use in measuring the muscle mass and hydration in
patients receiving radiation therapy is considered investigational. The study doctor can
explain how mBCA is designed to work in more detail.

Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria:

1. Age > 18 years

2. Histologically documented head and neck cancer (Clinical Stage I-IVB; Tx,1-4, N0-3)

3. Patients dispositioned to receive radiation therapy (dose > 60 Gy)

4. Patients may receive radiation as either primary therapy or post-operatively

5. Patient received staging positron emission tomography/computed tomography (PET/CT)
scan during 30-day period prior to initiating therapy.

6. Negative pregnancy test for women of child bearing potential

Exclusion Criteria:

1. Previous radiation treatment for head and neck mucosal primary cancers (i.e.
oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity)

2. Patients with pacemaker, implanted cardiac defibrillator, or vagal nerve stimulator

3. Pregnant or breast-feeding females

4. Patients weighing over 660 lbs (300 kg).

5. Patients with other medical conditions known to cause sarcopenia, including New York
Heart Association (NYHA) class III-IV heart failure, oxygen-dependent pulmonary
disease, advanced human immunodeficiency virus infection, cirrhosis, end stage renal
disease, or inherited/congenital disorders of metabolism.

6. Patients receiving palliative irradiation.