Hematopoietic and Lymphatic System Neoplasm
Conditions
Brief summary
This clinical trial examines sustained oral fiber supplementation for patients undergoing treatment for hematological malignancies. Patients undergoing cancer treatment, including 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 treatment for hematological malignancies.
Detailed description
OUTLINE: Current study design: Patients receive fiber supplementation orally (PO) or enterally starting 14 to 5 days prior to standard of care treatment and continuing until day 42 post-treatment. 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_SUPPLEMENTKate Farms 1.0
Given enteral nutrition via nasoenteric feeding
DIETARY_SUPPLEMENTStandard of Care Nutritional Support
Given standard of care, which may be parenteral nutrition
OTHERSurvey Administration
Ancillary studies
DIETARY_SUPPLEMENTDietary Supplement
Receive fiber supplementation orally or enterally
PROCEDUREBiospecimen Collection
Undergo collection of blood and stool samples
OTHERElectronic Health Record Review
Ancillary studies
OTHERFiber and Dietary Assessments
Ancillary studies
Sponsors
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to provide written informed consent prior to initiation of any study procedures * Any diagnosed hematological malignancy * At least 18 years of age * Planned treatment at Fred Hutchinson Cancer Center and/or University of Washington Medical Center
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study participation rates | Assessed at consenting | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of comfort/distress attributed to initiating and maintaining oral fiber intake | Up to 90 days following treatment | The post-discharge questions measuring level of comfort or distress experienced with each nutritional treatment will be tabulated. |
| Incidence of adverse events | Up to 90 days following treatment | Will assess safety including diarrhea, abdominal pain, bloating. |
| Tolerance of initiating and maintaining oral fiber intake | Up to 90 days following treatment | 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. |
| Number of days receiving any amount of fiber | Up to 90 days following treatment | — |
| Number of days receiving at least 10 grams of fiber | Up to 90 days following treatment | — |
| Number of days receiving at least 25 grams of fiber | Up to 90 days following treatment | — |
Countries
United States
Contacts
CONTACTDavid Fredricks
PRINCIPAL_INVESTIGATORDavid Fredricks
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed