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

NCT04829136 | Recruiting DMC

• 3 other identifiers: RG1121363NCI-2021-0084210599
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematopoietic and Lymphatic System Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed at consenting

Secondary Outcomes (5)

• Number of days receiving at least 10 grams of fiber

  Up to 90 days following transplant

• Number of days receiving at least 25 grams of fiber

  Up to 90 days following transplant

• Tolerance of initiating and maintaining oral fiber intake

  Up to 90 days following transplant

• Level of comfort/distress attributed to initiating and maintaining oral fiber intake

  Up to 90 days following transplant

• Incidence of adverse events

  Up to 90 days following transplant

Study Arms (3)

Arm I (enteral nutrition) [Discontinued in January 2024]

EXPERIMENTAL

Patients receive enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge.

Dietary Supplement: Kate Farms 1.0; Other: Survey Administration

Arm II (standard of care) [Discontinued in January 2024]

ACTIVE COMPARATOR

Patients receive standard of care nutritional support.

Dietary Supplement: Standard of Care Nutritional Support; Other: Survey Administration

Supportive care (Fiber) [Current study activity]

EXPERIMENTAL

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.

Other: Survey Administration; Dietary Supplement: Dietary Supplement; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Fiber and Dietary Assessments

Interventions

Kate Farms 1.0 DIETARY_SUPPLEMENT

Given enteral nutrition via nasoenteric feeding

Also known as: Polymeric Enteral Nutrition Formula

Arm I (enteral nutrition) [Discontinued in January 2024]

Standard of Care Nutritional Support DIETARY_SUPPLEMENT

Given standard of care, which may be parenteral nutrition

Also known as: hyperalimentation, parenteral nutrition, Total Parenteral Nutrition, TPN

Arm II (standard of care) [Discontinued in January 2024]

Survey Administration OTHER

Ancillary studies

Arm I (enteral nutrition) [Discontinued in January 2024]; Arm II (standard of care) [Discontinued in January 2024]; Supportive care (Fiber) [Current study activity]

Dietary Supplement DIETARY_SUPPLEMENT

Receive fiber supplementation orally or enterally

Also known as: nutritional supplement, supplemental nutrition, Supplements

Supportive care (Fiber) [Current study activity]

Biospecimen Collection PROCEDURE

Undergo collection of blood and stool samples

Supportive care (Fiber) [Current study activity]

Electronic Health Record Review OTHER

Ancillary studies

Supportive care (Fiber) [Current study activity]

Fiber and Dietary Assessments OTHER

Ancillary studies

Supportive care (Fiber) [Current study activity]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent prior to initiation of any study procedures
• Planned allogeneic stem cell transplantation
• At least 18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Interventions

Parenteral Nutrition; Parenteral Nutrition, Total; Dietary Supplements; Dietary Fiber

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Carbohydrates; Carbohydrates

Study Officials

• David Fredricks

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Fredricks

CONTACT

206-667-1935; dfredric@fredhutch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: April 2, 2021
• Study Start: June 22, 2022
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)