Overview
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.
Description
- OUTLINE
Current study design: Patients receive fiber supplementation orally (PO) or enterally starting 14 days prior to day 1 of 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.
Eligibility
Inclusion Criteria:
- Able to provide written informed consent prior to initiation of any study procedures
- Planned allogeneic stem cell transplantation with planned hospital admission for transplant
- At least 18 years of age
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