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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT04829136
Status
Recruiting
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Conditions

  • Hematopoietic and Lymphatic System Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Kate Farms 1.0 — DIETARY_SUPPLEMENT
    Given enteral nutrition via nasoenteric feeding
  • Standard of Care Nutritional Support — DIETARY_SUPPLEMENT
    Given standard of care, which may be parenteral nutrition
  • Survey Administration — OTHER
    Ancillary studies
  • Dietary Supplement — DIETARY_SUPPLEMENT
    Receive fiber supplementation orally or enterally
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood and stool samples
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Fiber and Dietary Assessments — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Jun 22, 2022
Status verified
Mar 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm I (enteral nutrition) [Discontinued in January 2024]
    Patients receive enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge.
  • Active Comparator: Arm II (standard of care) [Discontinued in January 2024]
    Patients receive standard of care nutritional support.
  • Experimental: 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.

Primary Outcome Measure

Study participation rates [ Time Frame: Assessed at consenting ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
David Fredricks
[email protected]
206-667-1935
David Fredricks (PRINCIPAL_INVESTIGATOR)

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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