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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Head and Neck Carcinoma

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02615275

P30CA016672 (U.S. NIH Grant/Contract)

PA15-0600 (Other Identifier)

NCI-2018-02603 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Supportive Care (bioelectrical impedance analysis, RT)

Experimental group

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.

Treatment:

Radiation: Radiation Therapy

Procedure: Positron Emission Tomography

Procedure: Computed Tomography

Procedure: Bioelectric Impedance Analysis

Other: Questionnaire Administration

Other: Quality-of-Life Assessment