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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
Given enteral nutrition via nasoenteric feeding
Given standard of care, which may be parenteral nutrition
Ancillary studies
Receive fiber supplementation orally or enterally
Undergo collection of blood and stool samples
Ancillary studies
Ancillary studies
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
RECRUITINGStudy 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.
Time frame: Assessed at consenting
Number of days receiving at least 10 grams of fiber
Time frame: Up to 90 days following transplant
Number of days receiving at least 25 grams of fiber
Time frame: Up to 90 days following transplant
Tolerance of initiating and maintaining oral fiber intake
Tolerance of initiating and maintaining oral fiber intake (or via enteral nutrition) will be calculated as delivery of the intended amount on each day that nutritional supplementation was indicated.
Time frame: Up to 90 days following transplant
Level of comfort/distress attributed to initiating and maintaining oral fiber intake
The post-discharge questions measuring level of comfort or distress experienced with each nutritional treatment will be tabulated.
Time frame: Up to 90 days following transplant
Incidence of adverse events
Will assess safety including diarrhea, abdominal pain, bloating.
Time frame: Up to 90 days following transplant
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