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Gluten Free Diet for AML Patients Undergoing Induction Chemotherapy
This randomized phase II trial studies how well a gluten free diet works in diminishing side effects in patients with acute myeloid leukemia undergoing induction chemotherapy. A gluten free diet may result in less intestinal side effects and blood infections during the induction chemotherapy compared to a standard diet.
PRIMARY OBJECTIVES: 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Start Date
July 27, 2017
Primary Completion Date
November 14, 2017
Completion Date
November 14, 2017
Last Updated
November 17, 2017
1
ACTUAL participants
Best Practice
OTHER
Biospecimen Collection
PROCEDURE
Dietary Intervention
OTHER
Laboratory Biomarker Analysis
OTHER
Lead Sponsor
Rutgers, The State University of New Jersey
Collaborators
NCT06285890
NCT06220162
NCT04065399
Data Source & Attribution
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