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

Head and Neck Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02615275
• Other study ID #: PA15-0600
• Secondary ID: NCI-2018-02603PA
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 24, 2015
• Est. completion date: November 30, 2026

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This information may help researchers make decisions about nutritional supplementation and the placement of feeding tubes in patients receiving radiation therapy.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Carcinoma
• Head and Neck Neoplasms

Intervention

Procedure:
• Bioelectric Impedance Analysis
Undergo BIA with seca mBCA
• Computed Tomography
Undergo CT
• Positron Emission Tomography
Undergo PET

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Radiation:
• Radiation Therapy
Undergo RT

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bioelectrical impedance analysis (BIA) estimates of total body water	a. Bioelectrical impedance analysis (BIA) estimates of total body water (kg)	Up to 2 years
Other	The incidence of unplanned hospitalizations	b. incidence of unplanned hospitalizations (#)	Up to 2 years
Other	Lean body mass as a predictor of sarcopenia	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
Other	Lean body mass as a predictor of therapeutic feeding tube use	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
Other	Quality of life assessed questionnaire	a. MD Anderson Symptom Inventory-Head and Neck (MDASI-HN)	Baseline up to 12 months
Other	Quality of life questionnaire	b. Brief patient interviews to assess performance status (ECOG PS) Scores 0-5	Baseline up to 12 months
Primary	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	BIA-derived body composition calculations	Root mean square error analysis will be utilized to quantify the average error from BIA-derived body composition calculations.	Up to 2 years

External Links

•   MD Anderson Cancer Center Website