Topical Corticosteroid and Bacterial Decolonization to Prevent Radiation Dermatitis: A Randomized Controlled Trial and Quality of Life Assessment
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Incidence of grade >2 RD
研究概览
简要总结
The purpose of this study is to determine whether bacterial decolonization of the nares and skin, topical steroid therapy, or a combination of the two regimens prior to treatment with radiotherapy (RT) for breast and head and neck cancer patients can prevent grade 2 or higher grade radiation dermatitis (RD) graded via the Common Terminology Criteria for Adverse Events (CTCAE) scale and improve quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
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 greater than or equal to 18
- •Diagnosis of a breast or head and neck cancer with plans for fractionated RT (greater than or equal to 15 fractions in 40 Gy (Gray)) with curative intent, including post-operative patients deemed eligible for RT by their surgeons and radiation oncologists
排除标准
- •Prior RT to the region of interest
- •Existing dermatologic condition affecting the treatment area (eg: atopic dermatitis, psoriasis, and non-healing wounds; known allergy to intervention therapies)
研究组 & 干预措施
Bacterial decolonization
Validated decolonization regimen
干预措施: Bacterial decolonization (Drug)
Topical corticosteroid
Mometasone furoate 0.1% cream
干预措施: Mometasone furoate 0.1% cream (Drug)
Combination
Validated decolonization regimen and mometasone furoate 0.1% cream
干预措施: Bacterial decolonization and Mometasone furoate 0.1% cream (Drug)
结局指标
主要结局
Incidence of grade >2 RD
时间窗: Two weeks after RT treatment completed
Assessed via the CTCAE scale before and after RT treatment via clinical photographs graded by a blinded dermatologist (minimum grade 0, maximum grade 5, higher score is worse outcome)
次要结局
- Quality of life Score Change(Two weeks after RT treatment completed)