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

Oral Chronic Graft-versus-host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686855
• Other study ID #: 08-027
• Status: Completed
• Phase: Phase 2
• First received: May 27, 2008
• Last updated: February 24, 2014
• Start date: August 2008
• Est. completion date: March 2013

Study information

• Verified date: February 2014
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft vs Host Disease
• Oral Chronic Graft-versus-host Disease

Intervention

Drug:
• Tacrolimus
Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks
• Dexamethasone
Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks

Locations

Country	Name	City	State
United States	Beth-Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Beth Israel Deaconess Medical Center, Children's Hospital Boston, Dana-Farber Cancer Institute, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No