Oral fiber supplementation for patients receiving stem cell transplants
Feasibility of Implementing Sustained Oral Fiber Supplementation for Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Hematological Malignancies
This study is testing if taking extra fiber can help people getting stem cell transplants feel better and improve their gut health during treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fred Hutchinson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT04829136 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of sustained oral fiber supplementation in patients undergoing donor stem cell transplantation for hematological malignancies. The study aims to improve nutrition and gut function in patients who often experience gastrointestinal damage due to chemotherapy, radiotherapy, or graft-versus-host disease. Participants will receive fiber supplementation starting 14 to 5 days prior to their conditioning chemotherapy and continuing until discharge, with follow-up assessments at 42, 60, and 90 days post-transplant. Blood samples will also be collected throughout the study to monitor health outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for allogeneic stem cell transplantation.
Not a fit: Patients with major psychiatric diagnoses that impair cognitive functioning or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance nutritional support and gut health for patients undergoing stem cell transplants, potentially leading to better recovery outcomes.
How similar studies have performed: Previous studies have explored nutritional interventions in similar patient populations, indicating potential benefits, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to provide written informed consent prior to initiation of any study procedures * Planned allogeneic stem cell transplantation * At least 18 years of age Exclusion Criteria: * Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team * Pregnant or breastfeeding. Pregnancy test is obtained as part of pre-transplant evaluation in women of child-bearing potential at arrival to transplant and again within 7 days of conditioning and will be confirmed as negative by review of the chart
Where this trial is running
Seattle, Washington
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: David Fredricks — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: David Fredricks
- Email: dfredric@fredhutch.org
- Phone: 206-667-1935
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.