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

PRIMARY OBJECTIVES:

I. To determine the feasibility of executing the High Fiber Program in HCT patients.

II. To estimate the proportion of patients who restore fiber intake to baseline levels by day 60 post-HCT.

SECONDARY OBJECTIVES:

I. To estimate the median number of days post-HCT when allogeneic HCT (alloHCT) patients achieve baseline fiber intake levels.

II. To obtain estimates of fiber intake in the pre-HCT period and over time in alloHCT patients on the High Fiber Program.

III. To evaluate the variety of fiber sources that patients have included in their diet by day 100.

IV. To evaluate the tolerability of introducing fiber into patients' diets based on when patients resume fiber intake post-transplant and the frequency of medications for controlling gastrointestinal symptoms.

V. To characterize toxicities associated with introducing fiber into patients' diets.

VI. To evaluate the median day of onset of acute GVHD and cumulative incidence of grade 2 or higher acute graft-versus (vs)-host disease (GVHD), per Mount Sinai Acute Graft Versus Host Disease International Consortium Grading System (MAGIC) criteria, at day +100 post-HCT, including incidence and severity of lower gastrointestinal acute GVHD.

VII. To evaluate incidence and severity of infections per Blood and Marrow Transplant Clinical Trials Network (BMT CTN) criteria, including bloodstream infections, up to day 100.

VIII. To obtain estimates of correlation between fiber intake and quality of life scores at day 100 post-HCT.

IX. To estimate the proportion of patients who achieve a fiber intake of at least 25g on at least one day by day 100 post-HCT.

X. To evaluate the cumulative incidence of chronic GVHD at 180 days, 1 year and 2 years post-HCT in patients on the High Fiber Program.

XI. To estimate overall survival (OS) and cumulative incidence of relapse/progression and non-relapse mortality at 100 days, 1 year and 2 years post-HCT in patients on the High Fiber Program.

EXPLORATORY OBJECTIVES:

I. To assess the feasibility of obtaining patient reported side effects and medications for symptom relief during the pre-screening period.

II. To assess how fiber intake influences immune reconstitution pattern over the course of therapy.

III. To evaluate how fiber intake relates to fecal/intestinal microbiome composition over the course of therapy.

IV. To assess relationships between fiber intake and serum inflammatory cytokines over the course of therapy.

V. To assess relationships between fiber intake and acute GVHD biomarkers, especially Reg3a produced by intestinal enterocytes.

VI. To evaluate how fiber intake relates to fecal metabolite levels over the course of therapy.

VII. To evaluate whether fiber intake relates to calorie intake over the course of therapy.

OUTLINE:

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 once a week (QW) and select food options from Fiber Aware Menu during admission. Additionally, patients receive a study booklet and undergo blood sample collection on study.

After completion of study intervention, patients are followed up on days 72, 100, and 180 and years 1 and 2.