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

N/AActive Not RecruitingNCT02615275

M.D. Anderson Cancer Center50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Carcinoma

Interventions

Bioelectric Impedance AnalysisPROCEDURE

Undergo BIA with seca mBCA

Computed TomographyPROCEDURE

Undergo CT

Positron Emission TomographyPROCEDURE

Undergo PET

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 7 weeks

Secondary Outcomes

BIA-derived body composition calculations

Root mean square error analysis will be utilized to quantify the average error from BIA-derived body composition calculations.

Time frame: Up to 2 years

Data from ClinicalTrials.gov

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