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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| Boston Children's Hospital | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
| Massachusetts General Hospital |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus | Experimental | Tacrolimus Arm Closed to Accrual as of January 2012 |
|
| Dexamethasone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants were assessed at Baseline and 4 weeks after start of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathaniel Treister, DMD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Brigham and Women's Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone | Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks |
| FG001 | Tacrolimus | Tacrolimus Arm Closed to Accrual as of January 2012 Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone | Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks |
| BG001 | Tacrolimus | Tacrolimus Arm Closed to Accrual as of January 2012 Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Of the 46 participants enrolled on the trial, 36 were deemed evaluable for response. | Posted | Number | participants | Participants were assessed at Baseline and 4 weeks after start of therapy |
|
Adverse events were collected during the four week peroid participants took the study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone | Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment | deemed unrelated to study treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain - Oral Cavity | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nathaniel S. Treister, DMD, DMSc | Dana-Farber Cancer Institute | 617-632-2806 | ntreister@partners.org |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011246 | Pregnadienetriols |
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| OTHER |
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| Dexamethasone |
| Drug |
Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks |
|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Beth-Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Tacrolimus | Tacrolimus Arm Closed to Accrual as of January 2012 Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks |
|
|
| 0 |
| 28 |
| 1 |
| 28 |
| EG001 | Tacrolimus | Tacrolimus Arm Closed to Accrual as of January 2012 Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks | 1 | 18 | 1 | 18 |
|
| Infection Gr0-2 neutrophils - oral cavity | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
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| D011245 |
| Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |