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

This study has been completed.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Children's Hospital Boston
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Information provided by (Responsible Party):
Nathaniel S. Treister, DMD, DMSc, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00686855
First received: May 27, 2008
Last updated: February 24, 2014
Last verified: February 2014

May 27, 2008
February 24, 2014
August 2008
December 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
To evaluate and characterize the clinical efficacy of topical steroid and topical tacrolimus therapies for the treatment of oral cGHVD. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00686855 on ClinicalTrials.gov Archive Site
Not Provided
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Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease
An Open Label Phase II Randomized Trial of Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease

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)

  • 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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Oral Chronic Graft-versus-host Disease
  • Drug: Tacrolimus
    Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks
  • Drug: Dexamethasone
    Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
  • Experimental: Tacrolimus
    Tacrolimus Arm Closed to Accrual as of January 2012
    Intervention: Drug: Tacrolimus
  • Experimental: Dexamethasone
    Intervention: Drug: Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
4 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00686855
08-027
Yes
Nathaniel S. Treister, DMD, DMSc, Dana-Farber Cancer Institute
Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
  • Children's Hospital Boston
  • Beth Israel Deaconess Medical Center
  • Massachusetts General Hospital
Principal Investigator: Nathaniel Treister, DMD Brigham and Women's Hospital
Dana-Farber Cancer Institute
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP