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

NCT02615275 | Active Not Recruiting

• 3 other identifiers: PA15-0600NCI-2018-02603P30CA016672
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Carcinoma

Outcome Measures

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)

  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 Outcomes (1)

• BIA-derived body composition calculations

  Up to 2 years

Other Outcomes (6)

• Bioelectrical impedance analysis (BIA) estimates of total body water

  Up to 2 years

• The incidence of unplanned hospitalizations

  Up to 2 years

• Lean body mass as a predictor of sarcopenia

  Up to 2 years

Study Arms (1)

Supportive Care (bioelectrical impedance analysis, RT)

EXPERIMENTAL

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; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy

Interventions

Bioelectric Impedance Analysis PROCEDURE

Undergo BIA with seca mBCA

Also known as: BIA, Bioelectric Impedance, Bioelectric Impedance Test, Bioelectrical Impedance Analysis, Bioimpedance Analysis

Supportive Care (bioelectrical impedance analysis, RT)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography

Supportive Care (bioelectrical impedance analysis, RT)

Positron Emission Tomography PROCEDURE

Undergo PET

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Supportive Care (bioelectrical impedance analysis, RT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive Care (bioelectrical impedance analysis, RT)

Questionnaire Administration OTHER

Ancillary studies

Supportive Care (bioelectrical impedance analysis, RT)

Radiation Therapy RADIATION

Undergo RT

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation

Supportive Care (bioelectrical impedance analysis, RT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy; Radiotherapy; Radiation

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Therapeutics; Physical Phenomena

Study Officials

• Clifton D Fuller

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: November 26, 2015
• Study Start: November 24, 2015
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)