Conditions: Oral Chronic Graft-versus-host Disease
Keywords: tacrolimus dexamethasone oral rinse
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 46
Healthy volunteers: no

Brief summary:
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:
* 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.

Arms:
arm 1: Tacrolimus Arm Closed to Accrual as of January 2012 arm 2: None

Interventions: intervention 1: Tacrolimus intervention 2: Dexamethasone
Intervention descriptions: intervention 1: Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks intervention 2: Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks

Protocol document: