NCT04469075进行中（未招募）2 期
The PROTECT Study: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy With Clindamycin and Triamcinolone in Glioblastoma Patients Treated With Tumor Treating Fields
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 8
- 主要终点
- Number of patients without grade 2 or higher skin toxicity
研究概览
简要总结
The participants are being treated with Tumor Treating Fields (TTFields) for malignant glioma, and this type of treatment may cause skin-related side effects. This study will test whether using clindamycin and triamcinolone topical lotions can prevent skin-related side effects of TTFields.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Diagnosis of newly diagnosed or recurrent GBM with plan to initiate treatment with TTFields with or without systemic therapy, confirmed by the enrolling institution
- •Able to self-administer topical interventions or has available another person who can apply the topical agents
- •Treatment with TTF should be initiated within 7 days of planned initiation on this trial.
排除标准
- •Known history of allergy to any ingredient of the study agents
- •Preexisting scalp disorders such as psoriasis or dermatitis that, in the opinion of the investigator, will affect the grading of skin adverse events, confirmed by enrolling institution.
- •Use of concurrent topical therapy to the scalp for another dermatologic condition
- •Active, uncontrolled infection requiring systemic or oral antibiotic therapy within 14 days of enrollment
- •Use of greater than 4 mg dexamethasone a day within 14 days of enrollment
- •Malignant glioma
- •Pregnant Women
研究组 & 干预措施
topical clindamycin and triamcinolone
Experimental
Patients who are scheduled to receive TTFields therapy for newly diagnosed GBM will be treated with: topical clindamycin (or approved equivalent) 1% and triamcinolone 0.1%. Participating sites may use an alternative equivalent form of clindamycin, such as a gel, with MSK PI approval
干预措施: Triamcinolone Acetonide (Drug)
topical clindamycin and triamcinolone
Experimental
Patients who are scheduled to receive TTFields therapy for newly diagnosed GBM will be treated with: topical clindamycin (or approved equivalent) 1% and triamcinolone 0.1%. Participating sites may use an alternative equivalent form of clindamycin, such as a gel, with MSK PI approval
干预措施: Clindamycin Phosphate (Drug)
结局指标
主要结局
Number of patients without grade 2 or higher skin toxicity
时间窗: up to 120 days
device-related skin adverse events by investigator assessment.
次要结局
- skin-related quality of life(up to 120 days)
研究者
研究点 (8)
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