Head and Neck CarcinomaNCT02615275
Bioelectrical Impedance Analysis in Estimating Body Composition in Patients With Stage I-IV Head and Neck Cancer Undergoing Radiation Therapy
A study testing Bioelectric Impedance Analysis, Computed Tomography and Positron Emission Tomography in people with Head and Neck Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma
- What is being tested?
- Bioelectric Impedance Analysis, Computed Tomography and Positron Emission Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2015to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Head and Neck Carcinoma
- Being tested
- Bioelectric Impedance Analysis, Computed Tomography, Positron Emission Tomography, Quality-of-Life Assessment, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioelectric Impedance AnalysisProcedure or surgery
Also called BIA, Bioelectric Impedance, Bioelectric Impedance Test, Bioelectrical Impedance Analysis
Undergo BIA with seca mBCA
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, computerized tomography
Undergo CT
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Irradiate, Irradiated, irradiation
Undergo RT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Bioelectric Impedance Analysis; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 weeks
Secondary outcomes (1)
BIA-derived body composition calculations
Root mean square error analysis will be utilized to quantify the average error from BIA-derived body composition calculations.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study start24 Nov 2015
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Clifton D Fuller, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615275
- Sponsor's protocol ID
- PA15-0600
- Other IDs
- NCI-2018-02603, PA15-0600, P30CA016672
- Status last verified
- Oct 2026
- First submitted
- 24 Nov 2015
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Eight-Electrode Multifrequency Bioelectrical Impedance Analysis to Estimate Body Composition in a Head and Neck Cancer Population Undergoing Radiation Therapy
- ClinicalTrials.gov ID
- NCT02615275
- Acronym / sponsor ID
- PA15-0600
- Conditions
- Head and Neck Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Nov 2015 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVES:
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (bioelectrical impedance analysis, RT) | Experimental | Procedure: Bioelectric Impedance Analysis, Procedure: Computed Tomography, Procedure: Positron Emission Tomography, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Radiation: Radiation TherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioelectric Impedance AnalysisAlso: BIA, Bioelectric Impedance, Bioelectric Impedance Test, Bioelectrical Impedance AnalysisUndergo BIA with seca mBCA | Procedure or surgery | Supportive Care (bioelectrical impedance analysis, RT) |
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, computerized tomographyUndergo CT | Procedure or surgery | Supportive Care (bioelectrical impedance analysis, RT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET | Procedure or surgery | Supportive Care (bioelectrical impedance analysis, RT) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive Care (bioelectrical impedance analysis, RT) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (bioelectrical impedance analysis, RT) |
| Radiation TherapyAlso: Cancer Radiotherapy, Irradiate, Irradiated, irradiationUndergo RT | Radiation | Supportive Care (bioelectrical impedance analysis, RT) |
Primary outcome
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.
1 secondary outcome
BIA-derived body composition calculations
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clifton D Fuller principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioelectric Impedance Analysis, Computed Tomography and Positron Emission Tomography in people with Head and Neck Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.