NCT02615275

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Head and Neck Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Bioelectric Impedance Analysis	Undergo BIA with seca mBCA
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Positron Emission Tomography	Undergo PET
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Radiation Therapy	Undergo RT

Timeline

• Start date: 2015-11-24
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2015-11-26
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States