Acute Myeloid Leukemia Clinical Trial

Clinical Trial Finder Acute Myeloid Leukemia Trials

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

See Locations Near You

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.

View Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

1

Study ID:

NCT03108911

Recruitment Status:

Terminated

Sponsor:

Rutgers, The State University of New Jersey

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

1

Study ID:

NCT03108911

Recruitment Status:

Terminated

Sponsor:


Rutgers, The State University of New Jersey

How clear is this clinincal trial information?

Clinical Trial Resources

Why I’d Choose a Clinical Trial For Myself
SurvivorNet’s Guide To Clinical Trials: What Are They And Are They Right for You?
Clinical Trials Can be Life-Saving for Some
×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider