Health TrialsbyHealthPanel

Sustained Oral Fiber Supplementation for Patients Undergoing Treatment for Hematological Malignancies

ConditionHematopoietic and Lymphatic System Neoplasm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFred Hutchinson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Kate Farms 1.0

    Dietary supplement

    Given enteral nutrition via nasoenteric feeding

  • Standard of Care Nutritional Support

    Dietary supplement

    Given standard of care, which may be parenteral nutrition

  • Survey Administration

    Other intervention

    Ancillary studies

  • Dietary Supplement

    Dietary supplement

    Receive fiber supplementation orally or enterally

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood and stool samples

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Fiber and Dietary Assessments

    Other intervention

    Ancillary studies

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Arm I (enteral nutrition) [Discontinued in January 2024]Experimental treatment 2 interventions
Group B: Arm II (standard of care) [Discontinued in January 2024]Active comparator 2 interventions
Group C: Supportive care (Fiber) [Current study activity]Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Number of days receiving any amount of fiber

Time frame
Up to 90 days following treatment
2

Number of days receiving at least 10 grams of fiber

Time frame
Up to 90 days following treatment
3

Number of days receiving at least 25 grams of fiber

Time frame
Up to 90 days following treatment
4

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.

Time frame
Up to 90 days following treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fred Hutchinson Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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