This phase I trial studies the best dose and how well high dose vitamin A works in preventing gastrointestinal graft versus host disease (GVHD) in patients undergoing donor stem cell transplant. Vitamin A deficiency is associated with increased risk of gastrointestinal GVHD. Vitamin A regulates growth and differentiation of intestinal cells and may reduce risk of gastrointestinal GVHD.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03719092.
PRIMARY OBJECTIVE:
I. To determine the biologically effective and tolerable dose (BETD) level of pretransplant single, high dose vitamin A supplementation in adult allogeneic stem cell transplant recipients.
SECONDARY OBJECTIVE:
I. To evaluate the feasibility of collecting stool and profiling the gut microbiome in relation to Vitamin A.
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 cohorts.
TREATMENT COHORT: Patients receive vitamin A compound orally (PO) or enterally once prior to stem cell transplant. Patients may receive vitamin A compound PO or enterally two weeks after stem cell transplant if vitamin A levels have not improved by at least 10%.
CONTROL COHORT: Patients receive usual care.
After completion of study treatment, patients are followed up periodically.
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorHannah Choe
