Feasibility Clinical Study of Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change in Hair loss defined as grade 1 (thinning or patchy) or grade 2 (complete) alopecia (hair loss), as per Common Toxicity Criteria for Adverse Effects (CTCAE) version 3
研究概览
简要总结
This study hypothesizes that in patients undergoing whole brain radiotherapy, a compression headband will decrease the percentage of patients with significant hair loss following radiation.
详细描述
This is a pilot feasibility study. The primary objective of this study is to seek preliminary information to answer the following question:
- Does a compression headband, placed only at the time of irradiation, reduce the incidence of significant hair loss after whole brain radiation, as compared to historical controls?
This study will also seek to answer these secondary questions: 2. Is a temporary compression headband well tolerated in patients undergoing whole brain radiation? 3. If a portion of patients do have significant hair loss after radiation in spite of compression banding, what is the timing of hair regrowth? 4. In normal volunteers, does a compression headband cause acute hypoxia in the scalp, as measured by a transcutaneous oxygen pressure monitor, and, if so, to what degree?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Age greater than or equal to 18 years old.
- •Undergoing whole brain radiation therapy, using lateral opposed fields
- •Total planned radiation prescription dose between 30 Gy and 37.5 Gy in 10 to 15 treatments.
排除标准
- •Current complete or near-complete alopecia (natural or chemotherapy-induced)
- •Concurrent or sequential chemotherapy with an agent known to commonly cause alopecia (Adriamycin, Cytoxan, Ifosfamide, Taxol (greater than 50 mg/m2), or Vincristine).
- •Previous Radiation to the Scalp
- •Any active dermatologic disease affecting the scalp, or temporal arteritis
- •History of severe headaches.
结局指标
主要结局
Change in Hair loss defined as grade 1 (thinning or patchy) or grade 2 (complete) alopecia (hair loss), as per Common Toxicity Criteria for Adverse Effects (CTCAE) version 3
时间窗: baseline to 6 weeks
The primary outcome of this study will be the presence of "significant hair loss" by 6 weeks after the completion of whole brain radiation. This will be defined as grade 1 (thinning or patchy) or grade 2 (complete) alopecia (hair loss), as per Common Toxicity Criteria for Adverse Effects (CTCAE) version 3. The amount of hair loss will be evaluated at the following time points. * Before whole brain radiation * six weeks following radiation
次要结局
- Temporary compression headband side effects (Nausea, Headache, Redness, Tingling) in patients undergoing whole brain radiation(6 weeks)
- Timing of hair regrowth(one year)
- Acute hypoxia in the scalp of normal volunteers caused by compression headband (if present, to what degree?) as measured by a transcutaneous oxygen pressure monitor(1 hour)
研究者
Michael Milano, MD,PhD
Assoc Professor, Radiation Oncology
University of Rochester