Sustained Oral Fiber Supplementation for Patients Undergoing Donor Stem Cell Transplantation for Hematological Malignancies

Fred Hutchinson Cancer Center (FHCC)

Status: Enrolling

Conditions: Hematopoietic and Lymphatic System Neoplasm

Treatments: Dietary Supplement: Kate Farms 1.0; Procedure: Biospecimen Collection; Other: Fiber and Dietary Assessments; Dietary Supplement: Dietary Supplement; Other: Electronic Health Record Review; Dietary Supplement: Standard of Care Nutritional Support; Other: Survey Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT04829136

RG1121363

NCI-2021-00842 (Registry Identifier)

10599

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Arm I (enteral nutrition) [Discontinued in January 2024]

Experimental group

Description:

Patients receive enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge.

Treatment:

Other: Survey Administration

Dietary Supplement: Kate Farms 1.0

Arm II (standard of care) [Discontinued in January 2024]

Active Comparator group

Description:

Patients receive standard of care nutritional support.

Treatment:

Other: Survey Administration

Dietary Supplement: Standard of Care Nutritional Support

Supportive care (Fiber) [Current study activity]

Experimental group

Description:

Patients receive fiber supplementation PO or enterally starting 14 to 5 days prior to standard of care conditioning chemotherapy and continuing until discharge from the hospital. Stool will be collected at different time points throughout the study. Patients may also undergo blood sample collection throughout the study.

Treatment:

Other: Survey Administration

Other: Electronic Health Record Review

Dietary Supplement: Dietary Supplement

Other: Fiber and Dietary Assessments

Procedure: Biospecimen Collection