RecruitingNot ApplicableNCT04829136

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

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


Sponsor

Fred Hutchinson Cancer Center

Enrollment

30 participants

Start Date

Jun 22, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria2

  • 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

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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


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT04829136


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