Feasibility of Implementing Sustained Oral Fiber Supplementation for Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Hematological Malignancies
Fred Hutchinson Cancer Center
Summary
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.
Description
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 nasoen…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Able to provide written informed consent prior to initiation of any study procedures * Planned allogeneic stem cell transplantation * At least 18 years of age Exclusion Criteria: * Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team * 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…
Interventions
- Dietary SupplementKate Farms 1.0
Given enteral nutrition via nasoenteric feeding
- Dietary SupplementStandard of Care Nutritional Support
Given standard of care, which may be parenteral nutrition
- OtherSurvey Administration
Ancillary studies
- Dietary SupplementDietary Supplement
Receive fiber supplementation orally or enterally
- ProcedureBiospecimen Collection
Undergo collection of blood and stool samples
- OtherElectronic Health Record Review
Ancillary studies
- Other
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington