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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])


Phase 0
19 Years
N/A
Open (Enrolling)
Both
Brain Cancer

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Trial Information

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])


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

To evaluate the use of Bioelectrical Impedance Analysis as a clinical assessment tool in Glioblastoma Multiforme patients

Outcome Description:

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.

Outcome Time Frame:

Participants will be followed every 3 months up to 12 months

Safety Issue:

No

Principal Investigator

Louis B Nabors, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Food and Drug Administration

Study ID:

UAB 1106

NCT ID:

NCT01770626

Start Date:

April 2011

Completion Date:

May 2013

Related Keywords:

  • Brain Cancer
  • Brain Neoplasms
  • Glioblastoma

Name

Location

University of Alabama at BirminghamBirmingham, Alabama  35294-3300