Clinical trial · Interventional
Bioelectrical Impedance Analysis in Estimating Body Composition in Patients With Stage I-IV Head and Neck Cancer Undergoing Radiation Therapy
Validation of Eight-Electrode Multifrequency Bioelectrical Impedance Analysis to Estimate Body Composition in a Head and Neck Cancer Population Undergoing Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Carcinoma | Head and Neck Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bioelectric Impedance Analysis | Procedure | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive Care (bioelectrical impedance analysis, RT)
- description
- 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.
- interventionNames
- Procedure: Bioelectric Impedance Analysis
- Procedure: Computed Tomography
- Procedure: Positron Emission Tomography
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Radiation: Radiation Therapy
Primary outcomes (1)
- 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)
- timeFrame
- 7 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available