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NCT Number: NCT02615275

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Head and Neck Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bioelectric Impedance Analysis

Procedure

Undergo BIA with seca mBCA

Other names: BIA, Bioelectric Impedance, Bioelectric Impedance Test, Bioelectrical Impedance Analysis, Bioimpedance Analysis

Computed Tomography

Procedure

Undergo CT

Other names: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography

Positron Emission Tomography

Procedure

Undergo PET

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

radiation therapy

Radiation

Undergo RT

Other names: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation

Primary outcomes

  1. 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)

    Time frame: 7 weeks

    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.

Secondary outcomes

  1. BIA-derived body composition calculations

    Time frame: Up to 2 years

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

Other outcomes

  1. Bioelectrical impedance analysis (BIA) estimates of total body water

    Time frame: Up to 2 years

    a. Bioelectrical impedance analysis (BIA) estimates of total body water (kg)

  2. The incidence of unplanned hospitalizations

    Time frame: Up to 2 years

    b. incidence of unplanned hospitalizations (#)

  3. Lean body mass as a predictor of sarcopenia

    Time frame: Up to 2 years

    Exploratory analyses will evaluate whether decreases in lean mass measured during treatment correlates to the presence of sarcopenia on follow up.

  4. Lean body mass as a predictor of therapeutic feeding tube use

    Time frame: Up to 2 years

    Exploratory analyses will evaluate whether decreases in lean mass measured during treatment correlates to the incidence of therapeutic feeding tube use.

  5. Quality of life assessed questionnaire

    Time frame: Baseline up to 12 months

    a. MD Anderson Symptom Inventory-Head and Neck (MDASI-HN)

  6. Quality of life questionnaire

    Time frame: Baseline up to 12 months

    b. Brief patient interviews to assess performance status (ECOG PS) Scores 0-5

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2015
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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