Acute Myeloid Leukemia
Conditions
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.
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.
Interventions
OTHERBest Practice
Receive standard diet
PROCEDUREBiospecimen Collection
Provide stool sample
OTHERDietary Intervention
Receive GFD
OTHERLaboratory Biomarker Analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate and severity of bacteremia with enteric organisms during AML induction therapy assessed using stool samples | 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 | 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 | 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. |
Countries
United States
Outcome results
None listed