This phase I trial studies the side effects and how well high dose vitamin A works in preventing gastrointestinal graft versus host disease (GVHD) in participants 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.
PRIMARY OBJECTIVES: 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, participants are followed up periodically.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
62
Given PO or enterally
Receive usual care
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Vitamin A dose that achieves level in the upper quartile of normal range for sex in at least 2/3 cases without dose limiting toxicity
Determining a Vitamin A dose administered within 14 days prior to transplant that maintains level in the upper quartile of normal range for sex at day 28 (+/- 7 days) after stem cell infusion as well as tolerable in adult allogeneic stem cell transplant recipients. determining a Vitamin A dose administered within 14 days prior to transplant that maintains level in the upper quartile of normal range for sex at day 28 (+/- 7 days) after stem cell infusion as well as tolerable in adult allogeneic stem cell transplant recipients.
Time frame: Up to day 28
Incidence of gastrointestinal graft versus host disease
Cumulative incidence of GI GVHD will be calculated and graphed.
Time frame: Up to day 180 after stem cell transplant
Incidence of Toxicity
The toxicity analysis will include summarization of the toxicity and tolerability will be tabulated by dose level and summarized. Severe (grade 3+) toxicities will be summarized as well by type as well as in summary format of hematologic vs. non-hematologic severe toxicity incidence.
Time frame: Up to 28 days
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