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

April 13, 2026 updated by: M.D. Anderson Cancer Center

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive Care (bioelectrical impedance analysis, RT)
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Radiation: Radiation Therapy
Undergo RT
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Radiation
  • Radiotherapeutics
  • RT
  • Therapy, Radiation
  • irradiation
  • RADIOTHERAPY
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • tomography
  • computerized tomography
  • CT SCAN
Procedure: Positron Emission Tomography
Undergo PET
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
Procedure: Bioelectric Impedance Analysis
Undergo BIA with seca mBCA
Other Names:
  • BIA
  • Bioelectric Impedance
  • Bioelectric Impedance Test
  • Bioelectrical Impedance Analysis
  • Bioimpedance Analysis

What is the study measuring?

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)
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.
7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Up to 2 years
The incidence of unplanned hospitalizations
Time Frame: Up to 2 years
b. incidence of unplanned hospitalizations (#)
Up to 2 years
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.
Up to 2 years
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.
Up to 2 years
Quality of life assessed questionnaire
Time Frame: Baseline up to 12 months
a. MD Anderson Symptom Inventory-Head and Neck (MDASI-HN)
Baseline up to 12 months
Quality of life questionnaire
Time Frame: Baseline up to 12 months
b. Brief patient interviews to assess performance status (ECOG PS) Scores 0-5
Baseline up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Clifton D Fuller, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2015

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

November 24, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimated)

November 26, 2015

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA15-0600 (Other Identifier: M D Anderson Cancer Center)
  • P30CA016672 (U.S. NIH Grant/Contract)
  • NCI-2018-02603 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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