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])
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Brain Cancer
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To evaluate the use of Bioelectrical Impedance Analysis as a clinical assessment tool in Glioblastoma Multiforme patients
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
- To compare estimated caloric needs determined by BIA and Harris Benedict Equation to Resting Energy Expenditure from Indirect Calorimetry(At initial visit until end of study.Participants will be followed for duration average of every 3 months)