Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease

Study Overview
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Brief Summary
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The purpose of this research study is to determine the effectiveness of topical steroid therapy (with a drug called dexamethasone) and topical tacrolimus therapy for the treatment of oral chronic Graft-Versus-Host Disease (cGVHD)

Detailed Description
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Because no one knows which study option is best, participants will be randomized into one of two study groups: topical dexamethasone or topical tacrolimus. Participants will take the medication by mouth rinse four times a day for 5 minutes at a time. After rinsing they will spit out the medication and will not be able to eat or drink for 15 minutes. Participants will also take anti-fungal medication (fluconazole) orally once a week. After two weeks on study treatment, participants will have a blood drawn to monitor tacrolimus levels. After the final treatment (4 weeks), participants will have the following tests and procedures: clinical examination; questionnaire; blood tests; oral culture; optional tissue biopsy.

Official Title
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An Open Label Phase II Randomized Trial of Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease

Conditions
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Oral Chronic Graft-versus-host Disease

Intervention / Treatment
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* Drug: Tacrolimus
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with oral chronic graft-versus-host disease Patients 4 years of age or older Stable cGVHD medication regimen for the four weeks prior to study enrollment Exclusion Criteria: Patients already on topical steroid or tacrolimus therapies

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tacrolimus<br>Tacrolimus Arm Closed to Accrual as of January 2012 | Drug: Tacrolimus<br>* Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks<br>|
| Experimental: Dexamethasone<br> | Drug: Dexamethasone<br>* Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD. | Participants were given a survey at the time of screening and 4 weeks after start of therapy. The participants self-reported three symptoms of oral cGVHD: oral sensitivity, mouth pain, and mouth dryness. Each symptom was given a score ranging from 0-10, with 0 as none and 10 as the worst. Improvement in subjective scores was defined as 3 points or further reduction from pre-treatment to post-treatment assessment. | Participants were assessed at Baseline and 4 weeks after start of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tacrolimus, dexamethasone, oral rinse