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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02603 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| PA15-0600 | Other Identifier | M D Anderson Cancer Center | |
| P30CA016672 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (bioelectrical impedance analysis, RT) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioelectric Impedance Analysis | Procedure | Undergo BIA with seca mBCA |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bioelectrical impedance analysis (BIA) estimates of total body water | a. Bioelectrical impedance analysis (BIA) estimates of total body water (kg) | Up to 2 years |
| The incidence of unplanned hospitalizations |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clifton D Fuller | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Computed Tomography | Procedure | Undergo CT |
|
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| Positron Emission Tomography | Procedure | Undergo PET |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Radiation Therapy | Radiation | Undergo RT |
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b. incidence of unplanned hospitalizations (#)
| Up to 2 years |
| 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 |
| 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 |
| Quality of life assessed questionnaire | a. MD Anderson Symptom Inventory-Head and Neck (MDASI-HN) | Baseline up to 12 months |
| Quality of life questionnaire | b. Brief patient interviews to assess performance status (ECOG PS) Scores 0-5 | Baseline up to 12 months |
| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
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