Bioelectrical Impedance Analysis in Estimating Body Composition in Patients With Stage I-IV Head and Neck Cancer Undergoing Radiation Therapy

Study Overview
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Brief Summary
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Bioelectrical impedance analysis measures body mass (the amount of muscle and fat in the body) and the level of hydration to help researchers identify patients who are losing muscle mass during radiation therapy. This information may help researchers make decisions about nutritional supplementation and the placement of feeding tubes in patients receiving radiation therapy.

Detailed Description
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PRIMARY OBJECTIVES: I. To validate body composition estimates derived from the seca (SECA) medical body composition analyzer (mBCA) bioelectrical impedance analysis (BIA) scale by comparing with computed tomography (CT) measured lean and fat body mass. SECONDARY OBJECTIVES: I. Evaluate sensitivity of mBCA to detect changes in body composition during treatment. II. Identify whether BIA-estimated loss of lean body mass (LBM) during treatment predicts development of sarcopenia. III. Determine whether BIA-derived estimates of body water correlate with requirements for intravenous (IV) hydration and unplanned hospital admissions. IV. Explore associations between body composition and symptom burden during treatment. OUTLINE: Patients undergo bioelectrical impedance analysis with seca mBCA and CT or positron emission tomography (PET) at baseline, weekly for 6-7 weeks during standard of care radiation therapy (RT), and at 10-12 weeks after completion of RT. After completion of study, patients are followed up every 3 months for 2 years.

Official Title
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Validation of Eight-Electrode Multifrequency Bioelectrical Impedance Analysis to Estimate Body Composition in a Head and Neck Cancer Population Undergoing Radiation Therapy

Conditions
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Head and Neck Carcinoma

Intervention / Treatment
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* Procedure: Bioelectric Impedance Analysis
* Procedure: Computed Tomography
* Procedure: Positron Emission Tomography
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Radiation: Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically documented head and neck cancer (clinical stage I-IVB; Tx,1-4, N0-3). Patients dispositioned to receive radiation therapy (dose >= 60 gray [Gy]). Patients may receive radiation as either primary therapy or post-operatively. Patient received staging positron emission tomography/computed tomography (PET/CT) scan during 60-day period prior to initiating therapy. Negative pregnancy test for women of child bearing potential. Exclusion Criteria: Previous radiation treatment for head and neck mucosal primary cancers (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity). Patients with pacemaker, implanted cardiac defibrillator, or vagal nerve stimulator. Pregnant or breast-feeding females. Patients weighing over 660 lbs (300 kg). 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. Patients receiving palliative irradiation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (bioelectrical impedance analysis, RT)<br>Patients undergo bioelectrical impedance analysis with seca mBCA and CT or PET at baseline, weekly for 6-7 weeks during standard of care RT, and at 10-12 weeks after completion of RT. | Procedure: Bioelectric Impedance Analysis<br>* Undergo BIA with seca mBCA<br>* Other names: Bioimpedance Analysis;Procedure: Computed Tomography<br>* Undergo CT<br>* Other names: tomography;Procedure: Positron Emission Tomography<br>* Undergo PET<br>* Other names: proton magnetic resonance spectroscopic imaging;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Radiation: Radiation Therapy<br>* Undergo RT<br>* Other names: Therapy, Radiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean and Fat Body Mass Composition from SECA mBCA BIA Scale Compared with Computed Tomography (CT) in Participants with Head and Neck Cancer Undergoing Radiation Therapy (RT) | Validation of BIA measures of body composition made by comparison with CT-based estimates of body composition. Linear regression analysis used to determine the relative agreement between lean body mass and fat body mass predicted from impedance measurement and CT imaging. | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BIA-derived body composition calculations | Root mean square error analysis will be utilized to quantify the average error from BIA-derived body composition calculations. | Up to 2 years |