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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00498 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 021702 | Other Identifier | Rutgers Cancer Institute of New Jersey | |
| P30CA072720 | U.S. NIH Grant/Contract | View source |
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limited resources
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Strair | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
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| Biospecimen Collection | Procedure | Provide stool sample |
|
| Dietary Intervention | Other | Receive GFD |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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