Brain CancerEarly Phase 1BEAMNCT01770626
A Pilot Study to Determine Nutrition Status in Glioblastoma Multiforme Patients
A Early Phase 1 study testing Nutrition in people with Brain Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Cancer
- What is being tested?
- Nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jun 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subjects with implanted pacemakers or defibrillators.
- Subjects who are pregnant.
- Subjects with edema.
- Subjects with an amputated extremity.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: 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 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.
Read the 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.
- Conditions
- Brain Cancer
- Being tested
- Nutrition
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: At initial visit until end of study.Participants will be followed for duration average of every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startApr 2011
- Primary completionJul 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis B Nabors, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770626
- Sponsor's protocol ID
- UAB 1106
- Acronym
- BEAM
- Status last verified
- Oct 2014
- First submitted
- 20 Dec 2012
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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])
- ClinicalTrials.gov ID
- NCT01770626
- Acronym / sponsor ID
- BEAM / UAB 1106
- Conditions
- Brain Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | No intervention | Other: Nutritionevaluate the composition of a participant's body, diagnosed with a brain tumor (glioblastoma multiforme) as determined by bioelectrical impedance analysis |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Subjects with implanted pacemakers or defibrillators.
- Subjects who are pregnant.
- Subjects with edema.
- Subjects with an amputated extremity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NutritionAnthropometrics, 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). | Other | Single arm |
Primary outcome
To evaluate the use of Bioelectrical Impedance Analysis as a clinical assessment tool in Glioblastoma Multiforme patients
Time frame: 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.
1 secondary outcome
To compare estimated caloric needs determined by BIA and Harris Benedict Equation to Resting Energy Expenditure from Indirect Calorimetry
Time frame: At initial visit until end of study.Participants will be followed for duration average of every 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis B Nabors, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nutrition in people with Brain Cancer, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the use of Bioelectrical Impedance Analysis as a clinical assessment tool in Glioblastoma Multiforme patients (time frame: Participants will be followed every 3 months up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2014.