Pilot Study to Evaluate the Feasibility of High Fiber Program in Patients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
City of Hope Medical Center
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.
Description
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 ev…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 con…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- OtherDietary Intervention
Attend High Fiber Program counseling sessions
- OtherDietary Intervention
Attend High Fiber Program weekly sessions
- OtherDietary Intervention
Make Fiber Aware Menu food selections
- OtherDietary Intervention
Receive study booklet
- OtherQuestionnaire Administration
Ancillary studies
Location
- City of Hope Medical CenterDuarte, California