Sustained Oral Fiber Supplementation for Patients Undergoing Donor Stem Cell Transplantation for Hematological Malignancies
NCT ID: NCT04829136
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2022-06-22
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (enteral nutrition) [Discontinued in January 2024]
Patients receive enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge.
Kate Farms 1.0
Given enteral nutrition via nasoenteric feeding
Survey Administration
Ancillary studies
Arm II (standard of care) [Discontinued in January 2024]
Patients receive standard of care nutritional support.
Standard of Care Nutritional Support
Given standard of care, which may be parenteral nutrition
Survey Administration
Ancillary studies
Supportive care (Fiber) [Current study activity]
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.
Survey Administration
Ancillary studies
Dietary Supplement
Receive fiber supplementation orally or enterally
Biospecimen Collection
Undergo collection of blood and stool samples
Electronic Health Record Review
Ancillary studies
Fiber and Dietary Assessments
Ancillary studies
Interventions
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Kate Farms 1.0
Given enteral nutrition via nasoenteric feeding
Standard of Care Nutritional Support
Given standard of care, which may be parenteral nutrition
Survey Administration
Ancillary studies
Dietary Supplement
Receive fiber supplementation orally or enterally
Biospecimen Collection
Undergo collection of blood and stool samples
Electronic Health Record Review
Ancillary studies
Fiber and Dietary Assessments
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planned allogeneic stem cell transplantation
* At least 18 years of age
Exclusion Criteria
* Pregnant or breastfeeding. Pregnancy test is obtained as part of pre-transplant evaluation in women of child-bearing potential at arrival to transplant and again within 7 days of conditioning and will be confirmed as negative by review of the chart
18 Years
ALL
No
Sponsors
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Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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David Fredricks
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2021-00842
Identifier Type: REGISTRY
Identifier Source: secondary_id
10599
Identifier Type: OTHER
Identifier Source: secondary_id
RG1121363
Identifier Type: -
Identifier Source: org_study_id
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