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Trial record 7 of 15 for:    gluten | Open Studies | United States

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2017 by Rutgers, The State University of New Jersey
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT03108911
First received: April 6, 2017
Last updated: April 11, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Acute Myeloid Leukemia
Other: Best Practice
Procedure: Biospecimen Collection
Other: Dietary Intervention
Other: Laboratory Biomarker Analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Supportive Care
Official Title: Gluten Free Diet for AML Patients Undergoing Induction Chemotherapy

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • 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

  • 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

  • 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.


Estimated Enrollment: 120
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: March 2023
Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Biospecimen Collection
Provide stool sample
Other: Dietary Intervention
Receive GFD
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions
Other: Laboratory Biomarker Analysis
Correlative studies
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: Best Practice
Receive standard diet
Other Names:
  • standard of care
  • standard therapy
Procedure: Biospecimen Collection
Provide stool sample
Other: Laboratory Biomarker Analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03108911

Locations
United States, New Jersey
Rutgers Cancer Institute of New Jersey Not yet recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Roger K. Strair    732-235-7298    strairrk@cinj.rutgers.edu   
Principal Investigator: Roger K. Strair         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Investigators
Principal Investigator: Roger Strair Rutgers Cancer Institute of New Jersey
  More Information

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03108911     History of Changes
Other Study ID Numbers: 021702
NCI-2017-00498 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
021702 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
P30CA072720 ( US NIH Grant/Contract Award Number )
Study First Received: April 6, 2017
Last Updated: April 11, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 24, 2017