High Fiber Program to see if more fiber helps patients after an allogeneic stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates a High Fiber Program for adults undergoing allogeneic hematopoietic cell transplantation. The primary goals are to see if the program is feasible and whether patients can restore their fiber intake to baseline by around 60 days after transplant. Secondary aims include timing of fiber reintroduction, variety of fiber sources, tolerability, and potential gut-related effects, including GVHD and infection outcomes, up to day 100. The study also looks at quality of life and the relationship between fiber intake and clinical outcomes. Diet-based interventions are implemented alongside standard transplant care at City of Hope with NCI collaboration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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)

Where it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting

Study contacts

• Principal investigator: Ryotaro Nakamura — City of Hope Medical Center
• Study coordinator: Jenny Paredes, PhD
• Email: jeparedes@coh.org
• Phone: 6262184673

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.