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

Feasibility of Implementing Sustained Oral Fiber Supplementation for Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Hematological Malignancies

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.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm
• Intervention / Treatment: Other: Survey Administration; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Dietary supplement: Standard of Care Nutritional Support; Dietary supplement: Kate Farms 1.0; Dietary supplement: Dietary Supplement; Other: Fiber and Dietary Assessments

Detailed Description

OUTLINE:

Current study design: Patients receive fiber supplementation orally (PO) or enterally starting 14 days prior to day 1 of 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Fredricks; Phone Number: 206-667-1935; Email: dfredric@fredhutch.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: David Fredricks; Phone Number: 206-667-1935; Email: dfredric@fredhutch.org
      • Principal Investigator: David Fredricks

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Able to provide written informed consent prior to initiation of any study procedures
• Planned allogeneic stem cell transplantation with planned hospital admission for transplant
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (enteral nutrition) [Discontinued in January 2024]; Patients receive enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge.	Other: Survey Administration; Ancillary studies; Dietary supplement: Kate Farms 1.0; Given enteral nutrition via nasoenteric feeding; Other Names: Polymeric Enteral Nutrition Formula
Active Comparator: Arm II (standard of care) [Discontinued in January 2024]; Patients receive standard of care nutritional support.	Other: Survey Administration; Ancillary studies; Dietary supplement: Standard of Care Nutritional Support; Given standard of care, which may be parenteral nutrition; Other Names: parenteral nutrition; hyperalimentation; Total Parenteral Nutrition; TPN
Experimental: Supportive care (Fiber) [Current study activity]; Patients receive fiber supplementation PO or enterally starting 14 days prior to day 1 of 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.	Other: Survey Administration; Ancillary studies; Procedure: Biospecimen Collection; Undergo collection of blood and stool samples; Other: Electronic Health Record Review; Ancillary studies; Dietary supplement: Dietary Supplement; Receive fiber supplementation orally or enterally; Other Names: supplemental nutrition; Supplements; nutritional supplement; Other: Fiber and Dietary Assessments; Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Assessed at consenting

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days receiving at least 10 grams of fiber		Up to 90 days following transplant
Number of days receiving at least 25 grams of fiber		Up to 90 days following transplant
Tolerance of initiating and maintaining oral fiber intake	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.	Up to 90 days following transplant
Level of comfort/distress attributed to initiating and maintaining oral fiber intake	The post-discharge questions measuring level of comfort or distress experienced with each nutritional treatment will be tabulated.	Up to 90 days following transplant
Incidence of adverse events	Will assess safety including diarrhea, abdominal pain, bloating.	Up to 90 days following transplant

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Investigators: Principal Investigator: David Fredricks, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: RG1121363; 10599 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); NCI-2021-00842 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No