Recruiting

Oral Fiber Supplementation

Sponsor:

Fred Hutchinson Cancer Center

Code:

NCT04829136

Conditions

Hematopoietic and Lymphatic System Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Kate Farms 1.0

Standard of Care Nutritional Support

Survey Administration

Dietary Supplement

Biospecimen Collection

Study Details

Brief summary:

This clinical trial examines sustained oral fiber supplementation for patients undergoing treatment for hematological malignancies. Patients undergoing cancer treatment, including 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 treatment for hematological malignancies.

Conditions

Hematopoietic and Lymphatic System Neoplasm

Study ID

NCT04829136

Start date

Jun 22, 2022

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Able to provide written informed consent prior to initiation of any study procedures
  • Any diagnosed hematological malignancy
  • At least 18 years of age
  • Planned treatment at Fred Hutchinson Cancer Center and/or University of Washington Medical Center

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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 treatment and continuing until day 42 post-treatment. Stool will be collected at different time points throughout the study. Patients may also undergo blood sample collection throughout the study.

Interventions

Kate Farms 1.0

Given enteral nutrition via nasoenteric feeding

Standard of Care Nutritional Support

Given standard of care, which may be parenteral nutrition

Survey Administration

Ancillary studies

Dietary Supplement

Receive fiber supplementation orally or enterally

Biospecimen Collection

Undergo collection of blood and stool samples

Electronic Health Record Review

Ancillary studies

Fiber and Dietary Assessments

Ancillary studies

Primary outcome measure

  • Study participation rates [ Time Frame: Assessed at consenting ]

Central Contacts and Locations

Central contacts

David Fredricks

206-667-1935dfredric@fredhutch.org

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

David Fredricks

206-667-1935dfredric@fredhutch.org

Principal Investigator:

David Fredricks

More Information

Sponsor

Fred Hutchinson Cancer Center

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fred Hutchinson Cancer Center on 2026-09-01.