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

Acute Myeloid Leukemia Clinical Trial

Official title:

Gluten Free Diet for AML Patients Undergoing Induction Chemotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03108911
• Other study ID #: 021702
• Secondary ID: NCI-2017-0049802
• Status: Terminated
• Phase: Phase 2
• First received: April 6, 2017
• Last updated: November 15, 2017
• Start date: July 27, 2017
• Est. completion date: November 14, 2017

Study information

• Verified date: November 2017
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 14, 2017
• Est. primary completion date: November 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Other:
• Best Practice
Receive standard diet

Procedure:
• Biospecimen Collection
Provide stool sample

Other:
• Dietary Intervention
Receive GFD
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Rate and severity of GI symptoms during AML induction therapy	To determine what the severity is if GI symptoms develops	Up to 30 days
Primary	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