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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

PRE-SCREENING INCLUSION: Documented informed consent of the participant and/or legally authorized representative

PRE-SCREENING INCLUSION: Age: ≥ 18 years

PRE-SCREENING INCLUSION: Within healthy body mass index (BMI) range 18-29 at the time of pre-screening consent

PRE-SCREENING INCLUSION: Ability to read and understand English for questionnaires

Disqualifiers

PRE-SCREENING EXCLUSION: Clinically significant uncontrolled illness

PRE-SCREENING EXCLUSION: Active infection requiring antibiotics

PRE-SCREENING EXCLUSION: History of chronic gastrointestinal conditions such as inflammatory bowel disease or Crohn's disease

PRE-SCREENING EXCLUSION: Medical contraindications to incorporating fiber in their diet as determined by the treating physician

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Dietary Intervention
  • Dietary Intervention
  • Dietary Intervention
  • Dietary Intervention
  • Questionnaire Administration

Treatment groups

44 Participants
are divided into 1 treatment group

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator