High Fiber Program for Cancer Patients Undergoing Transplant

JP
Overseen ByJenny Paredes, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a High Fiber Program can increase fiber intake in patients preparing for a stem cell transplant. The goal is to improve gut health and potentially prevent complications like GVHD, where donor cells attack the recipient's body. Participants will attend several sessions with a dietitian to learn about high-fiber foods and how to incorporate them into their diet. Those planning to undergo a stem cell transplant soon and able to manage a fiber-rich diet might be suitable candidates. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance transplant outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get a clear answer based on your specific situation.

What prior data suggests that the High Fiber Program is safe for cancer patients undergoing transplant?

Research has shown that a high-fiber diet may benefit patients who have undergone stem cell transplants. One study found that patients who consumed more fiber before and after their transplant experienced better survival rates and a lower risk of gut issues, such as GVHD (graft versus host disease). GVHD occurs when new cells attack the body's healthy cells, leading to symptoms like skin rashes or dry eyes.

High-fiber diets also appear to promote a healthier gut, which is crucial for recovery after a transplant. Patients with higher fiber intake had better outcomes and fewer complications. These findings suggest that the High Fiber Program, designed to help patients increase their fiber intake, is likely safe and could offer health benefits for those undergoing allogeneic hematopoietic cell transplant (HCT).12345

Why are researchers excited about this trial?

Unlike the standard of care for cancer patients undergoing transplant, which typically focuses on managing symptoms and preventing complications with medications and dietary supplements, the High Fiber Program uses a dietary approach to potentially improve patient outcomes. Researchers are excited about this trial because it involves regular dietitian-led counseling sessions and a specialized "Fiber Aware Menu" that integrates high fiber foods into the patients’ diet. This approach aims to enhance gut health, which could support immune function and recovery post-transplant, offering a non-invasive and holistic method that differs from traditional medical treatments.

What evidence suggests that the High Fiber Program is effective for increasing fiber intake in cancer patients undergoing transplant?

Research has shown that a high-fiber diet can benefit individuals undergoing allogeneic hematopoietic cell transplant (HCT). Studies have found that patients consuming more fiber tend to live longer and face a lower risk of graft versus host disease (GVHD), a common post-transplant issue. Specifically, one study discovered that a high-fiber diet correlates with a healthier gut and a reduced chance of severe GVHD in the digestive system. Additionally, patients on high-fiber diets have experienced slower disease progression and better treatment responses. This trial will evaluate the High Fiber Program, where participants will attend dietitian-led counseling sessions and follow a fiber-rich diet. These findings suggest that increasing fiber intake may enhance gut health and overall outcomes for HCT patients.16789

Who Is on the Research Team?

RN

Ryotaro Nakamura

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for people with cancer who are about to have an allogeneic stem cell transplant (receiving blood-forming cells from a donor). Participants should be able to follow dietary advice and complete questionnaires.

Inclusion Criteria

PRE-SCREENING INCLUSION: Documented informed consent of the participant and/or legally authorized representative
PRE-SCREENING INCLUSION: Within healthy BMI range 18-29 at the time of pre-screening consent
PRE-SCREENING INCLUSION: Ability to read and understand English for questionnaires
See 12 more

Exclusion Criteria

MAIN EXCLUSION: Clinically significant uncontrolled illness
MAIN EXCLUSION: Prospective participants unable to comply with all study procedures including feasibility/logistics issues per investigator judgment
PRE-SCREENING EXCLUSION: Any other condition contraindicating participation due to safety concerns per investigator judgment
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Transplant Counseling

Participants attend High Fiber Program dietitian-led counseling sessions up to 30 days and/or 18 days prior to scheduled HCT

2-4 weeks
5-6 visits (in-person)

Treatment

Participants receive High Fiber Program counseling and select food options from Fiber Aware Menu during admission and post-transplant

60 days
Weekly visits (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and dietary intake post-treatment

Up to 2 years
Visits on days 72, 100, 180, and years 1 and 2

What Are the Treatments Tested in This Trial?

Interventions

  • High Fiber Program

Trial Overview

The study tests if a dietitian-led High Fiber Program can help patients increase their fiber intake during and after their stem cell transplant. It includes counseling, food tracking, biospecimen collection, and surveys.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Supportive care (High Fiber Program)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

High-Fiber Diet Tied to Slower Multiple Myeloma ...

The study showed that patients who maintained higher fiber intake before and after allo-HCT had better OS, reduced risk for gastrointestinal ...

The Power of Fiber: How Diet Can Help Fight Cancer and ...

They tracked what the patients ate and found that those who ate more fiber had better overall survival rates, less GVHD and healthier gut ...

The impact of fibre and prebiotic interventions on outcomes ...

Meta-analyses. The impact of fibre and prebiotic interventions on outcomes in cancer and haematopoietic stem cell transplantation: A systematic review.

City of Hope Scientists Present Innovative Research on ...

Paredes and a team of researchers found that a high-fiber diet was associated with a reduced risk of acute GVHD in the lower gastrointestinal ...

Fred Hutch

Key findings include: • Patients on a high-fiber diet were 5 times more likely to respond to immunotherapy • These patients also showed improved ...

High-Fiber Diet Linked to Improved Stem Cell Transplant ...

the high-fiber group had significantly higher overall survival in an analysis extending to 24 months relative to day 12 of the study (P = .04).

High-Fiber Diets May Reduce Risk of GVHD after Bone ...

Dietary fiber supports a healthy gut microbiome, which reduce complications of GVHD following bone marrow and stem cell transplants.

Study Details | NCT07664670 | The High Fiber Program to ...

Research has shown that diets high in fiber may improve the environment and health of the gut as well as outcomes following transplant; however ...

High-Fiber Diet Linked to Improved Stem Cell Transplant, ...

the high-fiber group had significantly higher overall survival in an analysis extending to 24 months relative to day 12 of the study (P = .04).