NCT04829136

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematopoietic and Lymphatic System Neoplasm

Interventions

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

Timeline

• Start date: 2022-06-22
• Primary completion: 2027-07-31
• Completion: 2027-12-31
• First posted: 2021-04-02
• Last updated: 2026-03-12

Locations

1 site across 1 country: United States