An Open Label Phase II Randomized Trial of Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 5
- 主要终点
- The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD.
研究概览
简要总结
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)
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients already on topical steroid or tacrolimus therapies
研究组 & 干预措施
Tacrolimus
Tacrolimus Arm Closed to Accrual as of January 2012
干预措施: Tacrolimus (Drug)
Dexamethasone
干预措施: Dexamethasone (Drug)
结局指标
主要结局
The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD.
时间窗: Participants were assessed at Baseline and 4 weeks after start of therapy
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.
次要结局
未报告次要终点
研究者
Nathaniel S. Treister, DMD, DMSc
Principal Investigator
Dana-Farber Cancer Institute