Clinical trial NCT04829136: Sustained Oral Fiber Supplementation for Patients Undergoing Donor Stem Cell Transplantation for Hematological Malignancies
Official title: Feasibility of Implementing Sustained Oral Fiber Supplementation for Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphatic System Neoplasm
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* Able to provide written informed consent prior to initiation of any study procedures
* Planned allogeneic stem cell transplantation
* 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

Primary outcomes:
measure: Study participation rates
timeFrame: Assessed at consenting
Secondary outcomes:
measure: Number of days receiving at least 10 grams of fiber
timeFrame: Up to 90 days following transplant
measure: Number of days receiving at least 25 grams of fiber
timeFrame: Up to 90 days following transplant
measure: Tolerance of initiating and maintaining oral fiber intake
timeFrame: Up to 90 days following transplant
measure: Level of comfort/distress attributed to initiating and maintaining oral fiber intake
timeFrame: Up to 90 days following transplant
measure: Incidence of adverse events
timeFrame: Up to 90 days following transplant
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: David Fredricks
role: PRINCIPAL_INVESTIGATOR
References: