Gluten Free Diet in Diminishing Side Effects Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy
NCT ID: NCT03108911
Last Updated: 2017-11-17
Study Results
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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TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2017-07-27
2017-11-14
Brief Summary
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Detailed Description
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I. To determine if a gluten free diet (GFD) modulates the rate and severity of bacteremia and gastrointestinal toxicity (measured by total parenteral nutrition \[TPN\] or nothing by mouth \[NPO\] order) in patients undergoing standard acute myeloid leukemia (AML) induction chemotherapy.
SECONDARY OBJECTIVES:
I. To determine the tolerance of, and compliance with, a GFD in patients undergoing standard AML induction chemotherapy.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive GFD prepared by the hospital per dietary/nutrition pharmacy standards from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis.
GROUP II: Patients receive a standard diet for from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group I (GFD)
Patients receive GFD prepared by the hospital per dietary/nutrition pharmacy standards from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis.
Biospecimen Collection
Provide stool sample
Dietary Intervention
Receive GFD
Laboratory Biomarker Analysis
Correlative studies
Group II (standard diet)
Patients receive a standard diet for from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis.
Best Practice
Receive standard diet
Biospecimen Collection
Provide stool sample
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Best Practice
Receive standard diet
Biospecimen Collection
Provide stool sample
Dietary Intervention
Receive GFD
Laboratory Biomarker Analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No history of celiac disease or non-celiac gluten sensitivity
* No grade 3 or 4 gastrointestinal (GI) toxicity at time of initial screening
* No documented bacteremia at time of initial screening
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 at time of initial screening
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Principal Investigators
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Roger Strair
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Countries
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Other Identifiers
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NCI-2017-00498
Identifier Type: REGISTRY
Identifier Source: secondary_id
021702
Identifier Type: OTHER
Identifier Source: secondary_id
021702
Identifier Type: -
Identifier Source: org_study_id