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High Fiber Program for Patients Undergoing Allogeneic Hematopoietic Cell Transplant

This study is looking at whether the High Fiber Program can help patients increase their fiber intake after an allogeneic hematopoietic cell transplant (HCT). An HCT is a procedure where you receive blood-forming cells from a donor, which can help treat certain blood cancers. However, patients can experience complications like graft versus host disease (GVHD), where the new cells attack your body. The High Fiber Program includes counseling, weekly sessions, special menu choices, and a study booklet. Researchers want to see if patients can successfully follow the program and reach their normal fiber intake levels. They will also look at how well patients tolerate fiber and if it affects GVHD. You may be able to join if you are 18 or older, have a healthy body mass index (BMI), and can read English. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 44 participants. The study does not specify if it is randomized or blinded.
What's involved
You would attend High Fiber Program counseling and weekly sessions, make Fiber Aware Menu food selections, and receive a study booklet. You would also provide blood samples.
Compensation
Not stated in the trial record.
Follow-up
Your fiber intake and attendance at counseling sessions will be measured up to day 60. Other aspects, like fiber sources and GVHD, will be evaluated up to day 100.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07664670

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

Not Yet Recruiting
NAAges 18+InterventionalSupportive care
City of Hope Medical Center
~44 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:Biospecimen CollectionDietary InterventionQuestionnaire Administration

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of scheduled dietary counseling sessions attended and withdrawal status (Feasibility)
Measured over Up to day 60
+1 more outcome measured

Conditions

Hematopoietic and Lymphatic System Neoplasm

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Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope Medical Center

    Duarte, Californiastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ryotaro Nakamura · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Jenny Paredes, PhD
[email protected]
6262184673
Email the study team

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Eligibility criteria

Inclusion

MAIN INCLUSION: Documented informed consent of the participant and/or legally authorized representative
MAIN INCLUSION: Age: ≥ 18 years
Patients ≥ 75 years of age that are otherwise eligible to undergo allogeneic HCT are included
MAIN INCLUSION: Karnofsky performance status ≥ 70%
MAIN INCLUSION: Within healthy BMI range 18-29 at the time of consent
MAIN INCLUSION: Ability to read and understand English for questionnaires
MAIN INCLUSION: Patients receiving myeloablative or reduced intensity conditioning regimens
MAIN INCLUSION: Adequate organ function consistent with institutional standards for HCT
MAIN INCLUSION: Patients must be scheduled to receive HCT within 45 days of consent
MAIN INCLUSION: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 45 days prior to the start of conditioning)
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
MAIN INCLUSION: Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months post-HCT
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

Exclusion

MAIN EXCLUSION: Clinically significant uncontrolled illness
MAIN EXCLUSION: Active infection requiring antibiotics
MAIN EXCLUSION: History of chronic gastrointestinal conditions such as inflammatory bowel disease or Crohn's disease
MAIN EXCLUSION: Medical contraindications to incorporating fiber in their diet as determined by the treating physician
MAIN EXCLUSION: Self-reported major dietary restrictions limiting fiber intake
MAIN EXCLUSION: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
MAIN EXCLUSION: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

What this trial measures

  • Percent of scheduled dietary counseling sessions attended and withdrawal status (Feasibility)Up to day 60

    Feasibility in each patient will be assessed based on patient participating in ≥ 80% of scheduled dietary counseling sessions by the study dietitian and not withdrawing by day 60. Point estimates and corresponding 95% confidence intervals will be reported. Will be estimated with exact binomial 95% confidence intervals.

  • Highest daily fiber intakeBaseline up to day 60

    Point estimates and corresponding 95% confidence intervals will be reported. Will be estimated with exact binomial confidence intervals. Distributions of baseline and day +60 intake will be summarized.