RecruitingInterventional

Feasibility of Implementing Sustained Oral Fiber Supplementation for Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Hematological Malignancies

NCT ID: NCT04829136Sponsor: Fred Hutchinson Cancer CenterLast updated: 2026-05-06

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.

Detailed 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 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.

Arms & 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
OtherFiber and Dietary Assessments
Ancillary studies

Outcome measures

Primary

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.
Time frame: Assessed at consenting

Secondary

Number of days receiving at least 10 grams of fiber
Time frame: Up to 90 days following transplant
Number of days receiving at least 25 grams of fiber
Time frame: Up to 90 days following transplant
Tolerance of initiating and maintaining oral fiber intake
Time frame: Up to 90 days following transplant
Level of comfort/distress attributed to initiating and maintaining oral fiber intake
Time frame: Up to 90 days following transplant
Incidence of adverse events
Time frame: Up to 90 days following transplant

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 the chart

Study locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109

Recruiting

David Fredricks · Contact

206-667-1935 dfredric@fredhutch.org

David Fredricks · Principal Investigator