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

November 15, 2017 updated by: Rutgers, The State University of New Jersey

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Up to 30 days
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
Time Frame: Up to 30 days
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
Time Frame: Up to 30 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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