Head and Neck Carcinoma
Conditions
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.
Interventions
PROCEDUREBioelectric Impedance Analysis
Undergo BIA with seca mBCA
PROCEDUREComputed Tomography
Undergo CT
PROCEDUREPositron Emission Tomography
Undergo PET
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
RADIATIONRadiation Therapy
Undergo RT
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 7 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BIA-derived body composition calculations | Up to 2 years | Root mean square error analysis will be utilized to quantify the average error from BIA-derived body composition calculations. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Lean body mass as a predictor of sarcopenia | Up to 2 years | Exploratory analyses will evaluate whether decreases in lean mass measured during treatment correlates to the presence of sarcopenia on follow up. |
| Lean body mass as a predictor of therapeutic feeding tube use | Up to 2 years | Exploratory analyses will evaluate whether decreases in lean mass measured during treatment correlates to the incidence of therapeutic feeding tube use. |
| Bioelectrical impedance analysis (BIA) estimates of total body water | Up to 2 years | a. Bioelectrical impedance analysis (BIA) estimates of total body water (kg) |
| Quality of life questionnaire | Baseline up to 12 months | b. Brief patient interviews to assess performance status (ECOG PS) Scores 0-5 |
| Quality of life assessed questionnaire | Baseline up to 12 months | a. MD Anderson Symptom Inventory-Head and Neck (MDASI-HN) |
| The incidence of unplanned hospitalizations | Up to 2 years | b. incidence of unplanned hospitalizations (#) |
Countries
United States
Outcome results
None listed