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

Rutgers The State University of New Jersey

Status and phase: Terminated; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis; Other: Best Practice; Other: Dietary Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03108911

021702 (Other Identifier)

P30CA072720 (U.S. NIH Grant/Contract)

NCI-2017-00498 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Group I (GFD)

Experimental group

Description:

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.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Dietary Intervention

Procedure: Biospecimen Collection

Group II (standard diet)

Experimental group

Description:

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.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Best Practice

Procedure: Biospecimen Collection