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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00438 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 021701 | Other Identifier | Rutgers Cancer Institute of New Jersey | |
| P30CA072720 | U.S. NIH Grant/Contract | View source |
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Slow accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies how well a gluten free diet works in preventing graft versus host disease in patients who are undergoing a donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft versus host disease). A gluten free diet may decrease intestinal inflammation and graft versus host disease in patients who are undergoing a donor stem cell transplant.
PRIMARY OBJECTIVES:
I. To determine the rate and severity of gastrointestinal (GI) graft versus host disease (GVHD) in patients assigned to, and compliant with, a gluten free diet (GFD) during initial transplant hospitalization.
SECONDARY OBJECTIVES:
I. To determine the tolerance of, and compliance with, a GFD in patients undergoing allogeneic hematopoietic stem cell transplant (allo-SCT).
OUTLINE:
Patients undergo a gluten free diet for 30 days during initial hospitalization for allo-SCT, from the time of admission to discharge.
After completion of study, patients are followed up at 1, 3, 6, and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention (gluten free diet) | Experimental | Patients undergo a gluten free diet for 30 days during initial hospitalization for allo-SCT, from the time of admission to discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Intervention | Other | Undergo gluten free diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate and severity of stage 2-4 GI acute (a)GVHD as determined by microbiome analysis of stool samples | To determine how often patients develop gastrointestinal graft-versus-host disease at various times after transplant | Up to 12 months post allo-SCT |
| Rate and severity of all grade aGVHD and chronic GVHD as determined by microbiome analysis of stool samples | To determine what the severity is if graft-versus host disease develops. | Up to 12 months post allo-SCT |
| Rate of compliance with GFD | 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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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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