A Pilot Study to Determine Nutrition Status in Glioblastoma Multiforme Patients

Early Phase 1CompletedNCT01770626

University of Alabama at Birmingham40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Brain Cancer

Interventions

NutritionOTHER

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).

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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.

Time frame: Participants will be followed every 3 months up to 12 months

Secondary Outcomes

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.

Time frame: At initial visit until end of study.Participants will be followed for duration average of every 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.