NCT03108911

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

Gluten Free Diet for AML Patients Undergoing Induction Chemotherapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
OTHER	Best Practice	Receive standard diet
PROCEDURE	Biospecimen Collection	Provide stool sample
OTHER	Dietary Intervention	Receive GFD
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2017-07-27
• Primary completion: 2017-11-14
• Completion: 2017-11-14
• First posted: 2017-04-11
• Last updated: 2017-11-17

Locations

1 site across 1 country: United States