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| Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00391170 |
Purpose
This study will determine if a dexamethasone mouth rinse can reduce the risk of developing oral chronic graft-versus-host disease (cGVHD) in patients who have undergone a bone marrow (stem cell) transplant procedure. cGVHD is a common complication of stem cell transplantation, resulting from the donor cells attacking the transplant recipient's tissues. In oral cGVHD, the tissues in the mouth are damaged, causing painful mouth sores. Dexamethasone is a corticosteroid that is commonly used to treat inflammation. It is the only corticosteroid available that can be used as a mouth rinse.
Patients 12 years of age or older who have received a stem cell transplant may be eligible to participate if they are enrolled within 70 to 90 days of their transplant. Candidates are screened with a medical history and oral exam.
Participants are randomly assigned to receive either the dexamethasone rinse or a placebo (a solution that looks and tastes like the dexamethasone rinse but has no active medication). They undergo the following procedures:
Treatment with the study solution. Patients rinse their mouth with the dexamethasone solution or placebo three times a day for 3 months.
Clinic visits before starting treatment and at 1, 2 and 3 months after starting the study drug for the following procedures:
After treatment ends, participants are contacted by telephone every month for 6 months to report any symptoms of cGVHD, and they return to the clinic at 6 months for a final evaluation.
| Condition | Intervention | Phase |
|---|---|---|
|
Graft vs Host Disease |
Drug: Dexamethasone 0.01% Solution |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Pilot Study of Topical Dexamethasone 0.01% Solution for Prevention of Oral Chronic Graft Versus Host Disease |
| Estimated Enrollment: | 106 |
| Study Start Date: | October 2006 |
Prevention of oral GVHD by topical agents is an attractive strategy because it would potentially avoid the adverse effects associated with systemic immunosuppression. Topically administered dexamethasone solution is a commonly used agent for the treatment of oral inflammatory conditions including GVHD; however, the efficacy and systemic effects of topically administered dexamethasone solution are unknown. We therefore propose this trial designed to evaluate the efficacy and safety of topical dexamethasone solution for prevention of chronic oral GVHD in stem cell transplant recipients.
This phase II study will follow a randomized double-blind placebo controlled parallel group design. Consenting subjects who have undergone hematopoietic stem cell transplantation at the NIH Clinical Center will be randomized to receive dexamethasone 0.01% solution or placebo as an oral rinse for 3 months starting 90-100 days post-transplant. Subjects will be evaluated monthly after the start of intervention. Diagnostic and research evaluations will include a complete oral examination, oral mucosal biopsy prior to the beginning of the intervention (day -7) and at the time of development of oral GVHD or at the completion of intervention in the absence of clinical GVHD. We will measure serum dexamethasone levels and perform short cosyntropin (ACTH stimulation) test at the end of the 3-month intervention or onset of clinically significant GVHD.
The primary objective of the study is to evaluate the safety and efficacy of topical dexamethasone 0.01% solution used as an oral rinse for prevention of oral chronic graft versus host disease. Our primary endpoint will be the proportion of subjects that develop clinically significant (severity score 3 or higher) oral chronic GVHD by three months.
Secondary objectives will include the impact of oral graft versus host disease on the quality of life, characterization of the changes in tissue and salivary biomarkers associated with development of oral graft versus host disease, and measures of the effects of topical dexamethasone on hypothalamo-pituitary-adrenal axis. Secondary outcomes will include oral cavity specific quality of life as measured by OHIP-14 questionnaire, oral discomfort levels, improvement in general quality of life scores, and severity of oral GVHD as measured by the site-specific GVHD scoring system.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
History of allogeneic hematopoietic stem cell transplantation at the NIH Clinical Center within 70-90 days of enrollment.
Age 12 or older.
Ability to rinse and expectorate study medication rather than swallow it.
Ability and willingness to come to Clinical Center for monthly follow-up appointments and at the time of development of symptoms/signs suggestive of oral GVHD.
EXCLUSION CRITERIA:
Clinically significant oral GVHD at the time of the screening.
Active viral or fungal infection involving oral cavity not resolving by day 90.
Platelet count less than 20,000/ml at the time of the screening appointment.
Life expectancy less than 4 months at the time of enrollment.
Documented hypersensitivity to dexamethasone.
Pregnancy or lactation.
Inability to understand the investigational nature of the study ability to provide informed consent.
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| Responsible Party: | National Institutes of Health ( Jacinta D. Arrington, M.D./National Heart, Lung, and Blood Institute ) |
| Study ID Numbers: | 070005, 07-H-0005 |
| Study First Received: | October 20, 2006 |
| Last Updated: | October 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00391170 History of Changes |
| Health Authority: | United States: Federal Government |
|
Mucositis Topical Steroids Transplant Complication Oral Pain |
Oral Chronic Graft Versus Host Disease Oral Pain Mouth Pain |
|
Anti-Inflammatory Agents Dexamethasone Antineoplastic Agents, Hormonal Mucositis Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Pain |
Glucocorticoids Hormones Homologous Wasting Disease Graft Versus Host Disease Graft vs Host Disease Peripheral Nervous System Agents Dexamethasone acetate |
|
Anti-Inflammatory Agents Dexamethasone Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics |
Hormones Glucocorticoids Pharmacologic Actions Autonomic Agents Therapeutic Uses Graft vs Host Disease Peripheral Nervous System Agents Central Nervous System Agents Dexamethasone acetate |
