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

Primary Purpose

Oral Chronic Graft-versus-host Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tacrolimus
Dexamethasone
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Chronic Graft-versus-host Disease focused on measuring tacrolimus, dexamethasone, oral rinse

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tacrolimus

Dexamethasone

Arm Description

Tacrolimus Arm Closed to Accrual as of January 2012

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 27, 2008
Last Updated
February 24, 2014
Sponsor
Brigham and Women's Hospital
Collaborators
Dana-Farber Cancer Institute, Boston Children's Hospital, Beth Israel Deaconess Medical Center, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00686855
Brief Title
Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease
Official Title
An Open Label Phase II Randomized Trial of Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Dana-Farber Cancer Institute, Boston Children's Hospital, Beth Israel Deaconess Medical Center, Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Chronic Graft-versus-host Disease
Keywords
tacrolimus, dexamethasone, oral rinse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tacrolimus
Arm Type
Experimental
Arm Description
Tacrolimus Arm Closed to Accrual as of January 2012
Arm Title
Dexamethasone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Intervention Description
Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
Primary Outcome Measure Information:
Title
The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD.
Description
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.
Time Frame
Participants were assessed at Baseline and 4 weeks after start of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathaniel Treister, DMD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth-Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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