The High Fiber Program to Increase Fiber Intake Among Patients Undergoing Allogeneic Hematopoietic Cell Transplant

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07664670
Status
Not Yet Recruiting

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Conditions

  • Hematopoietic and Lymphatic System Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Dietary Intervention — OTHER
    Attend High Fiber Program counseling sessions
  • Dietary Intervention — OTHER
    Attend High Fiber Program weekly sessions
  • Dietary Intervention — OTHER
    Make Fiber Aware Menu food selections
  • Dietary Intervention — OTHER
    Receive study booklet
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

This clinical trial studies whether the High Fiber Program can be used to increase fiber intake in patients undergoing allogeneic hematopoietic cell transplant (HCT). Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical, donor. This is often a sister or brother, but could be an unrelated donor. It is a potentially curative therapy for many conditions that affect the blood and blood-forming organs, but many patients must manage post-transplant complications, especially graft versus host disease (GVHD). GVHD occurs when the transplanted cells from a donor attack the body's normal cells causing skin rash or blisters, dry mouth, or dry eyes. The environment and health of the gut is important in allogeneic HCT patients, with an unhealthy gut environment and/or health leading to inflammation and possibly GVHD. Research has shown that diets high in fiber may improve the environment and health of the gut as well as outcomes following transplant; however, fiber intake remains low among patients. The High Fiber Program is a dietitian-led counseling program which teaches patients how to introduce high fiber foods into their diet and identify food choices and personalized strategies that will help them change their diet. The High Fiber Program may be an effective way to increase fiber intake in patients undergoing allogeneic HCT.

Key Dates

Start date
Feb 13, 2027
Status verified
Jun 2026
Primary completion
Jun 3, 2028
Completion
Jun 3, 2028

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Supportive care (High Fiber Program)
    Patients attend five or six High Fiber Program dietitian-lead counseling sessions up to 30 days and/or 18 days prior to scheduled HCT, upon admission to inpatient care, at discharge, at day 42 post-transplant (approximately 20-30 days post-discharge), and at day 60 post-transplant. Patients also meet with High Fiber Program dietitian QW and select food options from Fiber Aware Menu during admission. Additionally, patients receive a study booklet and undergo blood sample collection on study.

Primary Outcome Measure

Percent of scheduled dietary counseling sessions attended and withdrawal status (Feasibility) [ Time Frame: Up to day 60 ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Ryotaro Nakamura
[email protected]
6262184673
Ryotaro Nakamura (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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