This study is NOT currently recruiting participants.
Number
07-H-0005
Sponsoring Institute
National Heart, Lung and Blood Institute (NHLBI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 12 Max Age: 110
Referral Letter Required
Yes
Population Exclusion(s)
Fetuses;Pregnant Women
Keywords
Oral Chronic GVHD; Topical Dexamethasone; Tissue Markers; Salivary Proteomics; Quality of Life
Recruitment Keyword(s)
Oral Chronic Graft Versus Host Disease; Oral Pain; Mouth Pain
Condition(s)
Graft vs Host Disease
Investigational Drug(s)
None
Investigational Device(s)
Intervention(s)
Drug: Topical Dexamethasone Other: Placebo
Supporting Site
National Heart, Lung, and Blood Institute
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:
-Oral exam (before starting treatment and at each visit).
-Photographs of the mouth (before starting treatment and at 3 months).
-Biopsy from inside the cheek (before starting treatment). The inside of the cheek is numbed and a small piece of tissue is removed for examination by a pathologist.
-Saliva sample collection (before starting treatment).
-Blood draw (before starting treatment and at each visit).
-Quality-of-life questionnaires (before starting treatment and at 3 months).
-Questionnaire to assess level of dry mouth and mouth pain (before starting treatment and at each visit).
-Review of medications (at each visit).
-ACTH stimulation test to evaluate adrenal gland function (at 3 months). Patients are given an injection of a drug called "ACTH" or "cosyntropin," which is a version of a hormone normally produced by the pituitary gland. Blood samples are drawn before the injection and at 30 and 60 minutes after the injection to measure levels of the hormone cortisol.
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.
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INCLUSION CRITERIA: 1. History of allogeneic hematopoietic stem cell transplantation within 60-90 days of enrollment. 2. Age 12 or older. 3. Ability to rinse and expectorate study medication rather than swallow it. 4. Ability and willingness to come to Clinical Center for follow-up appointments and at the time of development of symptoms/signs suggestive of oral GVHD. EXCLUSION CRITERIA: 1. Clinically significant oral chronic GVHD at the time of the screening. 2. Active viral or fungal infection involving oral cavity not resolving by day 90. 3. Platelet count less than 20,000/ml at the time of the screening appointment. 4. Life expectancy less than 4 months at the time of enrollment. 5. Documented hypersensitivity to dexamethasone. 6. Pregnancy or lactation. 7. Inability to understand the investigational nature of the study. 8. Inability to provide informed consent.
1. History of allogeneic hematopoietic stem cell transplantation within 60-90 days of enrollment.
2. Age 12 or older.
3. Ability to rinse and expectorate study medication rather than swallow it.
4. Ability and willingness to come to Clinical Center for follow-up appointments and at the time of development of symptoms/signs suggestive of oral GVHD.
EXCLUSION CRITERIA:
1. Clinically significant oral chronic GVHD at the time of the screening.
2. Active viral or fungal infection involving oral cavity not resolving by day 90.
3. Platelet count less than 20,000/ml at the time of the screening appointment.
4. Life expectancy less than 4 months at the time of enrollment.
5. Documented hypersensitivity to dexamethasone.
6. Pregnancy or lactation.
7. Inability to understand the investigational nature of the study.
8. Inability to provide informed consent.
Principal Investigator
Referral Contact
For more information: