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

Phase 2

Completed

• Conditions: Oral Chronic Graft-versus-host Disease
• Interventions: Drug: Tacrolimus; Drug: Dexamethasone

• Registration Number: NCT00686855
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-30
• Study Start: 2008-08
• Primary Completion: 2012-12
• Study Completion: 2013-03
• Results First Submitted: 2013-11-20
• Results First Submitted QC: 2014-01-05
• Status Verified: 2014-02
• Results First Posted: 2014-02-19
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tacrolimus	Tacrolimus	Tacrolimus Arm Closed to Accrual as of January 2012
Dexamethasone	Dexamethasone	-

Primary Outcome Measures

Name	Time	Method
The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD.	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.

Trial Locations

Locations (5)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States

Beth-Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States