Sustained Oral Fiber Supplementation for Patients Undergoing Treatment for Hematological Malignancies

Fred Hutchinson Cancer Center100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

100

Conditions

Hematopoietic and Lymphatic System Neoplasm

Interventions

Kate Farms 1.0DIETARY_SUPPLEMENT

Given enteral nutrition via nasoenteric feeding

Standard of Care Nutritional SupportDIETARY_SUPPLEMENT

Given standard of care, which may be parenteral nutrition

Survey AdministrationOTHER

Ancillary studies

Dietary SupplementDIETARY_SUPPLEMENT

Receive fiber supplementation orally or enterally

Biospecimen CollectionPROCEDURE

Undergo collection of blood and stool samples

Electronic Health Record ReviewOTHER

Ancillary studies

Fiber and Dietary AssessmentsOTHER

Ancillary studies

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Study 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