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

NCT03108911 | Terminated Phase 2

• 3 other identifiers: 021702NCI-2017-00498P30CA072720
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Group I (GFD)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Other: Dietary Intervention; Other: Laboratory Biomarker Analysis

Group II (standard diet)

EXPERIMENTAL

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: Best Practice; Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis

Interventions

Best Practice OTHER

Receive standard diet

Also known as: standard of care, standard therapy

Group II (standard diet)

Biospecimen Collection PROCEDURE

Provide stool sample

Group I (GFD); Group II (standard diet)

Dietary Intervention OTHER

Receive GFD

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Group I (GFD)

Laboratory Biomarker Analysis OTHER

Correlative studies

Group I (GFD); Group II (standard diet)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

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

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Practice Guidelines as Topic; Standard of Care; Diet Therapy

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Nutrition Therapy; Therapeutics

Study Officials

• Roger Strair

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 11, 2017
• Study Start: July 27, 2017
• Primary Completion: November 14, 2017
• Study Completion: November 14, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

US (1)