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

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.

Study Overview

• Status: Terminated
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Procedure: Biospecimen Collection; Other: Dietary Intervention; Other: Best Practice

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Cancer Institute of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group I (GFD); 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Procedure: Biospecimen Collection; Provide stool sample; Other: Dietary Intervention; Receive GFD; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions
EXPERIMENTAL: Group II (standard diet); 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: Laboratory Biomarker Analysis; Correlative studies; Procedure: Biospecimen Collection; Provide stool sample; Other: Best Practice; Receive standard diet; Other Names: standard of care; standard therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 27, 2017
• Primary Completion (ACTUAL): November 14, 2017
• Study Completion (ACTUAL): November 14, 2017

Study Registration Dates

• First Submitted: April 6, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (ACTUAL): April 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 15, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: 021702 (OTHER: Rutgers Cancer Institute of New Jersey); P30CA072720 (U.S. NIH Grant/Contract); NCI-2017-00498 (REGISTRY: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No