A Pilot Study to Determine Nutrition Status in Glioblastoma Multiforme Patients

Study Overview
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Brief Summary
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The study is designed to evaluate how the composition of a participant's body, diagnosed with a brain tumor (glioblastoma multiforme) as determined by bioelectrical impedance analysis can predict the progression and outcomes of disease.

Detailed Description
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The purpose of this study is to monitor the nutritional status of (Glioblastoma Multiforme)GBM patients for one year. We will look at the relationships between phase angle determined by Bioelectrical Impedance Analysis (BIA), nutrition assessment by Subjective Global Assessment and serum albumin, the type of microbes present in the gut, the participant's DNA information, and tumor progression. We will also compare estimated caloric needs determined by BIA and Harris Benedict Equation to Resting Energy Expenditure from Indirect Calorimetry of the people with GBM and the people without.

Official Title
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A Pilot Study to Determine the Effectiveness of Bioelectrical Impedance Analysis as a Clinical Assessment Tool of Nutrition Status in Glioblastoma Multiforme Patients (The BEAM Study [BIA Effectiveness as Assessment Tool for Glioblastoma Multiforme (GBM) Patients])

Conditions
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Brain Cancer

Intervention / Treatment
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* Other: Nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be at least 19 years of age. Subjects must have a histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme). Women of childbearing potential must have a negative pregnancy test. Exclusion Criteria: Subjects with implanted pacemakers or defibrillators. Subjects who are pregnant. Subjects with edema. Subjects with an amputated extremity.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Single arm<br>evaluate the composition of a participant's body, diagnosed with a brain tumor (glioblastoma multiforme) as determined by bioelectrical impedance analysis | Other: Nutrition<br>* Anthropometrics, Nutrition assessment, Bioelectrical Impedance Analysis, Blood sample, Resting Energy Expenditure. All will be done 2-3 weeks after initial study visit and will continue every 3 months study visit except the Resting Energy Expenditure which will be performed at only one visit (2-3 weeks after initial visit).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the use of Bioelectrical Impedance Analysis as a clinical assessment tool in Glioblastoma Multiforme patients | The electrical current used by the BIA (Bioelectrical Impedance Analysis) is low and below the level. The electrodes will be placed on hand and foot. | Participants will be followed every 3 months up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare estimated caloric needs determined by BIA and Harris Benedict Equation to Resting Energy Expenditure from Indirect Calorimetry | Age, sex, and body composition are the prime influences on resting energy expenditure (REE), the energy used by an individual when fasted and at rest. The largest component of total energy expenditure (TEE) is REE. | At initial visit until end of study.Participants will be followed for duration average of every 3 months |