Acute Myeloid Leukemia Clinical Trial
Official title:
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.
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