A Pilot Study to Determine Nutrition Status in Glioblastoma Multiforme Patients (BEAM)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||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])|
- To evaluate the use of Bioelectrical Impedance Analysis as a clinical assessment tool in Glioblastoma Multiforme patients [ Time Frame: Participants will be followed every 3 months up to 12 months ] [ Designated as safety issue: No ]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.
- To compare estimated caloric needs determined by BIA and Harris Benedict Equation to Resting Energy Expenditure from Indirect Calorimetry [ Time Frame: At initial visit until end of study.Participants will be followed for duration average of every 3 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
No Intervention: Single arm
evaluate the composition of a participant's body, diagnosed with a brain tumor (glioblastoma multiforme) as determined by bioelectrical impedance analysis
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01770626
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Rebecca V Barnhill, BS 205-975-8341 firstname.lastname@example.org|
|Contact: Louis B Nabors, MD 205-934-1813 email@example.com|
|Principal Investigator: Louis B Nabors, MD|
|Principal Investigator:||Louis B Nabors, MD||University of Alabama at Birmingham|