A Pilot Study to Determine Nutrition Status in Glioblastoma Multiforme Patients

Early Phase 1

Completed

• Conditions: Brain Cancer
• Interventions: Other: Nutrition

• Registration Number: NCT01770626
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2013-01-17
• Study First Posted: 2013-01-18
• Primary Completion: 2013-07
• Study Completion: 2014-06
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-25
• Last Update Posted: 2014-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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Exclusion Criteria

• Subjects with implanted pacemakers or defibrillators.
• Subjects who are pregnant.
• Subjects with edema.
• Subjects with an amputated extremity.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Nutrition	evaluate the composition of a participant's body, diagnosed with a brain tumor (glioblastoma multiforme) as determined by bioelectrical impedance analysis

Primary Outcome Measures

Name	Time	Method
To evaluate the use of Bioelectrical Impedance Analysis as a clinical assessment tool in Glioblastoma Multiforme patients	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 Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States