Clinical trial NCT02615275: Bioelectrical Impedance Analysis in Estimating Body Composition in Patients With Stage I-IV Head and Neck Cancer Undergoing Radiation Therapy
Official title: Validation of Eight-Electrode Multifrequency Bioelectrical Impedance Analysis to Estimate Body Composition in a Head and Neck Cancer Population Undergoing Radiation Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Head and Neck Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-11-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
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
Secondary outcomes:
measure: BIA-derived body composition calculations
timeFrame: Up to 2 years
Other outcomes:
measure: Bioelectrical impedance analysis (BIA) estimates of total body water
timeFrame: Up to 2 years
measure: The incidence of unplanned hospitalizations
timeFrame: Up to 2 years
measure: Lean body mass as a predictor of sarcopenia
timeFrame: Up to 2 years
measure: Lean body mass as a predictor of therapeutic feeding tube use
timeFrame: Up to 2 years
measure: Quality of life assessed questionnaire
timeFrame: Baseline up to 12 months
measure: Quality of life questionnaire
timeFrame: Baseline up to 12 months
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Clifton D Fuller
role: PRINCIPAL_INVESTIGATOR
References: