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

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04829136
• Other study ID #: RG1121363
• Secondary ID: NCI-2021-0084210
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: Fred Hutchinson Cancer Center
• Contact: David Fredricks
• Phone: 206-667-1935
• Email: dfredric[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematopoietic and Lymphoid Cell Neoplasm

Intervention

Dietary Supplement:
• Kate Farms 1.0
Given enteral nutrition via nasoenteric feeding
• 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
• Fiber and Dietary Assessments
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of days receiving at least 10 grams of fiber		Up to 90 days following transplant
Secondary	Number of days receiving at least 25 grams of fiber		Up to 90 days following transplant
Secondary	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
Secondary	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
Secondary	Incidence of adverse events	Will assess safety including diarrhea, abdominal pain, bloating.	Up to 90 days following transplant