Recruiting

High Fiber Program

Sponsor:

City of Hope Medical Center

Code:

NCT07664670

Conditions

Hematopoietic and Lymphatic System Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Dietary Intervention

Dietary Intervention

Dietary Intervention

Dietary Intervention

Study Details

Brief summary:

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.

Conditions

Hematopoietic and Lymphatic System Neoplasm

Study ID

NCT07664670

Start date

Feb 13, 2027

Status verified date

Nov, 2026

Completion date

Jun 3, 2028

Anticipated

Primary completion date

Jun 3, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

44 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Biospecimen Collection

Undergo blood sample collection

Dietary Intervention

Attend High Fiber Program counseling sessions

Dietary Intervention

Attend High Fiber Program weekly sessions

Dietary Intervention

Make Fiber Aware Menu food selections

Dietary Intervention

Receive study booklet

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Percent of scheduled dietary counseling sessions attended and withdrawal status (Feasibility) [ Time Frame: Up to day 60 ]
  • Highest daily fiber intake [ Time Frame: Baseline up to day 60 ]

Central Contacts and Locations

Central contacts

Jenny Paredes, PhD

6262184673jeparedes@coh.org

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Ryotaro Nakamura

RNakamura@coh.org

6262184673

Principal Investigator:

Ryotaro Nakamura

More Information

Sponsor

City of Hope Medical Center

Last update posted

Nov 5, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.