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
  Purpose

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)


Condition Intervention Phase
Oral Chronic Graft-versus-host Disease
Drug: Tacrolimus
Drug: Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Phase II Randomized Trial of Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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.


Enrollment: 46
Study Start Date: August 2008
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus
Tacrolimus Arm Closed to Accrual as of January 2012
Drug: Tacrolimus
Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks
Experimental: Dexamethasone Drug: Dexamethasone
Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks

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.
  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686855

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth-Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Children's Hospital Boston
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Investigators
Principal Investigator: Nathaniel Treister, DMD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Nathaniel S. Treister, DMD, DMSc, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00686855     History of Changes
Other Study ID Numbers: 08-027
Study First Received: May 27, 2008
Results First Received: November 20, 2013
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
tacrolimus
dexamethasone
oral rinse

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Tacrolimus
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 20, 2014