Feasibility of Implementing Sustained Oral Fiber Supplementation for Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Hematological Malignancies
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Able to provide written informed consent prior to initiation of any study procedures
• Planned allogeneic stem cell transplantation
• At least 18 years of age
Locations
United States
Washington
Fred Hutch/University of Washington Cancer Consortium
RECRUITING
Seattle
Contact Information
Primary
David Fredricks
dfredric@fredhutch.org
206-667-1935
Time Frame
Start Date: 2022-06-22
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Fred Hutchinson Cancer Center