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NCT Number: NCT04829136

Sustained Oral Fiber Supplementation for Patients Undergoing Donor Stem 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.

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Key information

Conditions

Hematopoietic and Lymphatic System Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location status: Recruiting

Location contact

David Fredricks

CONTACT

[email protected]

206-667-1935

David Fredricks

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kate Farms 1.0

Dietary Supplement

Given enteral nutrition via nasoenteric feeding

Other names: Polymeric Enteral Nutrition Formula

Standard of Care Nutritional Support

Dietary Supplement

Given standard of care, which may be parenteral nutrition

Other names: hyperalimentation, parenteral nutrition, Total Parenteral Nutrition, TPN

Survey Administration

Other

Ancillary studies

Dietary Supplement

Dietary Supplement

Receive fiber supplementation orally or enterally

Other names: nutritional supplement, supplemental nutrition, Supplements

Biospecimen Collection

Procedure

Undergo collection of blood and stool samples

Electronic Health Record Review

Other

Ancillary studies

Fiber and Dietary Assessments

Other

Ancillary studies

Primary outcomes

  1. Study participation rates

    Time frame: 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 outcomes

  1. Number of days receiving at least 10 grams of fiber

    Time frame: Up to 90 days following transplant

  2. Number of days receiving at least 25 grams of fiber

    Time frame: Up to 90 days following transplant

  3. Tolerance of initiating and maintaining oral fiber intake

    Time frame: Up to 90 days following transplant

    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.

  4. Level of comfort/distress attributed to initiating and maintaining oral fiber intake

    Time frame: Up to 90 days following transplant

    The post-discharge questions measuring level of comfort or distress experienced with each nutritional treatment will be tabulated.

  5. Incidence of adverse events

    Time frame: Up to 90 days following transplant

    Will assess safety including diarrhea, abdominal pain, bloating.

Study contacts

Contact information is provided by the study sponsor or research team.

David Fredricks

CONTACT

[email protected]

206-667-1935

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 2, 2021
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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