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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-00842 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10599 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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This clinical trial examines sustained oral fiber supplementation for patients undergoing donor stem cell transplantation for hematological malignancies. Patients undergoing donor stem cell transplantation often develop oral and gastrointestinal damage from chemotherapy, radiotherapy, or graft-versus-host disease. Oral fiber nutrition support may improve overall nutrition, support a normal gut microbiome (bacteria that live in the gut) and/or improve gut function in patients undergoing stem cell transplants.
OUTLINE:
Current study design: Patients receive fiber supplementation orally (PO) or enterally starting 14 to 5 days prior to standard of care conditioning chemotherapy and continuing until discharge. Patients who are not able to receive sufficient nutrition by mouth may receive parenteral nutrition or enteral nutrition by feeding tube from the hospital. Patients may undergo blood sample collection throughout the study.
Previous study design: Before this study was amended in January 2024, patients were randomized to 1 of 2 arms.
Previous Arm I: Patients received enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge.
Previous Arm II: Patients received standard of care nutritional support.
After completion of study treatment, patients are followed up at days 42, 60 and 90 days post transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (enteral nutrition) [Discontinued in January 2024] | Experimental | Patients receive enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge. |
|
| Arm II (standard of care) [Discontinued in January 2024] | Active Comparator | Patients receive standard of care nutritional support. |
|
| Supportive care (Fiber) [Current study activity] | Experimental | Patients receive fiber supplementation PO or enterally starting 14 to 5 days prior to standard of care conditioning chemotherapy and continuing until discharge from the hospital. Stool will be collected at different time points throughout the study. Patients may also undergo blood sample collection throughout the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kate Farms 1.0 | Dietary Supplement | Given enteral nutrition via nasoenteric feeding |
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| Measure | Description | Time Frame |
|---|---|---|
| Study participation rates | The proportion of eligible patients who consent to enroll in the study will be computed based on the number approached and estimated with 95% confidence intervals. | Assessed at consenting |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days receiving at least 10 grams of fiber | Up to 90 days following transplant | |
| Number of days receiving at least 25 grams of fiber | Up to 90 days following transplant | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Fredricks | Contact | 206-667-1935 | dfredric@fredhutch.org |
| Name | Affiliation | Role |
|---|---|---|
| David Fredricks | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Recruiting | Seattle | Washington | 98109 | United States |
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| Standard of Care Nutritional Support | Dietary Supplement | Given standard of care, which may be parenteral nutrition |
|
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| Survey Administration | Other | Ancillary studies |
|
| Dietary Supplement | Dietary Supplement | Receive fiber supplementation orally or enterally |
|
|
| Biospecimen Collection | Procedure | Undergo collection of blood and stool samples |
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| Electronic Health Record Review | Other | Ancillary studies |
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| Fiber and Dietary Assessments | Other | Ancillary studies |
|
| Tolerance of initiating and maintaining oral fiber intake |
Tolerance of initiating and maintaining oral fiber intake (or via enteral nutrition) will be calculated as delivery of the intended amount on each day that nutritional supplementation was indicated. |
| Up to 90 days following transplant |
| Level of comfort/distress attributed to initiating and maintaining oral fiber intake | The post-discharge questions measuring level of comfort or distress experienced with each nutritional treatment will be tabulated. | Up to 90 days following transplant |
| Incidence of adverse events | Will assess safety including diarrhea, abdominal pain, bloating. | Up to 90 days following transplant |
| ID | Term |
|---|---|
| D010288 | Parenteral Nutrition |
| D010289 | Parenteral Nutrition, Total |
| D019587 | Dietary Supplements |
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
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