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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01838 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Cohort (vitamin A compound) | Experimental | Participants receive vitamin A compound PO or enterally once prior to stem cell transplant. once over a given 24 hour period with or without food. We will re-dose at 2000 IU/kg (maximum 120,000 IU) if Week 2 Vitamin A levels remain within 10% of baseline Vitamin A. |
|
| Control Cohort (usual care) | Active Comparator | Patients receive usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin A Compound | Dietary Supplement | Given PO or enterally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of gastrointestinal graft versus host disease | Cumulative incidence of GI GVHD will be calculated and graphed. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance of Stool collection | Compliance rate of take-home kit completion and inpatient stool collection | Pre-transplant, day 0, day 14, and day 28 |
| Stool microbe and vitamin A correlation | Correlation between stool microbes and response to vitamin A supplementation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hannah Choe, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Best Practice | Other | Receive usual care |
|
|
| Up to 28 days |
| Pre-transplant, day 0, day 14, and day 28 |
| ID | Term |
|---|---|
| D014801 | Vitamin A |
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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