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

NCT07664670 | Not Yet Recruiting DMC

• 3 other identifiers: 25887NCI-2026-03804P30CA033572
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Percent of scheduled dietary counseling sessions attended and withdrawal status (Feasibility)

  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.

  Up to day 60

• Highest daily fiber intake

  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.

  Baseline up to day 60

Secondary Outcomes (14)

• Longitudinal dietary fiber intake

  Pre-hematopoietic cell transplant up to day +100 post-transplant

• Number of types of plant-based fiber sources included in diet

  Up to day 100

• Duration that patients were not able to consume fiber

  Up to day +100 post-transplant

• Incidence of gastrointestinal toxicities and attribution to fiber intake

  Up to day +100 post-transplant

• Frequency and doses of medications for constipation, diarrhea or any other gastrointestinal discomfort

  Up to day +100 post-transplant

Study Arms (1)

Supportive care (High Fiber Program)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Other: Dietary Intervention; Other: Questionnaire Administration

Interventions

Dietary Intervention OTHER

Attend High Fiber Program counseling sessions

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Supportive care (High Fiber Program)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Supportive care (High Fiber Program)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (High Fiber Program)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 75 years of age that are otherwise eligible to undergo allogeneic HCT are included
• If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Interventions

Specimen Handling; Diet Therapy

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Nutrition Therapy; Therapeutics

Study Officials

• Ryotaro Nakamura

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 24, 2026
• Study Start (Estimated): February 13, 2027
• Primary Completion (Estimated): June 3, 2028
• Study Completion (Estimated): June 3, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

US (1)