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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1
Receive standard diet
Provide stool sample
Receive GFD
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Rate and severity of bacteremia with enteric organisms during AML induction therapy assessed using stool samples
To determine how often patients develop bacteremia during AML induction therapy
Time frame: Up to 30 days
Rate and severity of GI symptoms during AML induction therapy
To determine what the severity is if GI symptoms develops
Time frame: Up to 30 days
Rate of compliance with GFD assessed using daily food intake diary
Adherence to diet will be recorded in a food diary. Compliance will be defined as \> 67% of meals being gluten free.
Time frame: Up to 30 days
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