A Pilot Study to Determine Nutrition Status in Glioblastoma Multiforme Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Brain Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Single arm

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

Group Type NO_INTERVENTION

Nutrition

Intervention Type OTHER

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).

Interventions

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Nutrition

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).

Intervention Type OTHER

Eligibility Criteria

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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.