An Open Label Phase II Randomized Trial of Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease
Overview
- Phase
- Phase 2
- Intervention
- Tacrolimus
- Conditions
- Oral Chronic Graft-versus-host Disease
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 46
- Locations
- 5
- Primary Endpoint
- The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Nathaniel S. Treister, DMD, DMSc
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
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
Arms & Interventions
Tacrolimus
Tacrolimus Arm Closed to Accrual as of January 2012
Intervention: Tacrolimus
Dexamethasone
Intervention: Dexamethasone
Outcomes
Primary Outcomes
The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD.
Time Frame: Participants were assessed at Baseline and 4 weeks after start of therapy
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.