Sustained Oral Fiber Supplementation for Patients Undergoing Donor Stem Cell Transplantation for Hematological Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Kate Farms 1.0, Standard of Care Nutritional Support, Survey Administration, Dietary Supplement.
- Who it may be relevant to
- Registry conditions: Hematopoietic and Lymphatic System Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Feasibility of Implementing Sustained Oral Fiber Supplementation for Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Hematological Malignancies
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.
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.
Interventions
- 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
Primary outcome measures
- Study participation rates [Time frame: Assessed at consenting]
Secondary outcome measures (5)
- 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 [Time frame: Up to 90 days following transplant]
- Level of comfort/distress attributed to initiating and maintaining oral fiber intake [Time frame: Up to 90 days following transplant]
- Incidence of adverse events [Time frame: Up to 90 days following 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Fred Hutch/University of Washington Cancer Consortium — Seattle
Identifiers
NCT: NCT04829136 · RG1121363 · NCI-2021-00842 · 10599