NCT02805075

Fructooligosaccharides in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant

Single Arm Dose-Escalation Trial of Fructo-Oligosaccharides in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot phase I trial studies the side effects and best dose of fructooligosaccharides in treating patients with blood cancer who are undergoing donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Nutritional supplements such as fructooligosaccharides may reduce the incidence of graft-versus-host disease in patients with blood cancer undergoing donor stem cell transplant.

Detailed description

PRIMARY OBJECTIVES: I. Conduct a dose escalation trial to determine the tolerability of the fructo-oligosaccharides prebiotic in allogeneic hematopoeitic stem cell transplant (HSCT) patients. OUTLINE: This is a dose escalation study. Patients receive fructooligosaccharides (FOS) orally (PO) twice daily (BID) for 21 days starting at 7 days before allogeneic hematopoietic stem cell transplant in the absence of disease progression or unexpected toxicity. After completion of study treatment, patients are followed for 100 days.

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm
• Recurrent Hematologic Malignancy

Interventions

Type	Name	Description
OTHER	Fructooligosaccharide	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-11-17
• Completion: 2017-11-17
• First posted: 2016-06-17
• Last updated: 2021-03-23

Locations

1 site across 1 country: United States