A Pilot Study to Determine Nutrition Status in Glioblastoma Multiforme Patients

NCT01770626 | Completed Early Phase 1 DMC

• 1 other identifier: UAB 1106
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Participants will be followed every 3 months up to 12 months

Secondary Outcomes (1)

• 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

Study Arms (1)

Single arm

NO INTERVENTION

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

Other: Nutrition

Interventions

Nutrition 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).

Single arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Louis B Nabors, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: January 18, 2013
• Study Start: April 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: June 1, 2014
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

US (1)