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NCT04829136NARecruiting

Sustained Oral Fiber Supplementation for Patients Undergoing Donor Stem Cell Transplantation for Hematological Malignancies

Fred Hutchinson Cancer Center

Start Date

6/22/2022

Completion Date

12/31/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DIETARY_SUPPLEMENT

Kate Farms 1.0

DIETARY_SUPPLEMENT

Standard of Care Nutritional Support

OTHER

Survey Administration

DIETARY_SUPPLEMENT

Dietary Supplement

PROCEDURE

Biospecimen Collection

OTHER

Electronic Health Record Review

OTHER

Fiber and Dietary Assessments

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Conditions

Hematopoietic and Lymphatic System Neoplasm

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington 98109

United States