Gluten Free Diet in Diminishing Side Effects Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Gluten Free Diet for AML Patients Undergoing Induction Chemotherapy

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Other: Best Practice
* Procedure: Biospecimen Collection
* Other: Dietary Intervention
* Other: Laboratory Biomarker Analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing AML induction chemotherapy with an anthracycline + cytarabine-based chemotherapy regimen 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: Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (GFD)<br>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. | Procedure: Biospecimen Collection<br>* Provide stool sample<br>Other: Dietary Intervention<br>* Receive GFD<br>* Other names: Nutritional Interventions;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|
| Experimental: Group II (standard diet)<br>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. | Other: Best Practice<br>* Receive standard diet<br>* Other names: standard therapy;Procedure: Biospecimen Collection<br>* Provide stool sample<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 30 days | 
| Rate and severity of GI symptoms during AML induction therapy | To determine what the severity is if GI symptoms develops | 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. | Up to 30 days |