Investigating the Efficacy of Scalp Sparing Radiotherapy Treatment to the Whole Brain: Examining the Effect of Hair Loss and Re-growth
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- To assess hair loss and hair regrowth in patients undergoing WBRT using VMAT via photographic assessment by independent professionals at intervals up to 16 weeks post end of treatment.
研究概览
简要总结
To investigate the use of a scalp sparing technique of radiotherapy treatment designed to treat the whole brain. Current treatment methods to treat the whole brain with radiotherapy result in complete alopecia as a side effect. Hair loss is usually patchy and uneven and re-growth similar and slow.
It is hoped that reducing the radiation dose to the hair bearing follicle on the scalp will reduce hair loss and increase the speed and evenness of re-growth.
详细描述
Rationale for conducting the SPARE study:
The purpose of this study is to evaluate the effect of delivering WBRT via the VMAT method on hair loss and subsequent re-growth. Hair loss has been found to have a negative impact on QoL and can be particularly stressful for patients with a very short life expectancy, this is already well documented. Trying to minimise this treatment side effect, as previously stated in the literature, is a worthwhile investigation. This study is not looking at any prescribed dose changes to the established, evidence based and well documented prescriptions for WBRT. SPARE is an observational study of hair loss and re-growth during and after a patient's prescribed clinical treatment.
Aims and Objectives;
- To observe hair loss and re-growth in patients undergoing Whole Brain Radiotherapy using the Volumetric Modulated Arc Therapy method of delivery.
As complete alopecia is expected in 100% of patients receiving conventionally delivered WBRT it will be considered a positive result if complete hair loss does not happen when using VMAT in this group of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Adults over 18
- •Positive cancer diagnosis
- •Either proven brain metastasis or prophylaxis for primary lung cancer
- •Have no epilating chemotherapy planned
- •Basic understanding of English
排除标准
- •Previous whole brain radiotherapy
- •Pregnant females
- •Unable to give informed consent
- •Urgent cases that need same or next day treatment when referred
结局指标
主要结局
To assess hair loss and hair regrowth in patients undergoing WBRT using VMAT via photographic assessment by independent professionals at intervals up to 16 weeks post end of treatment.
时间窗: 4 months post radiotherapy treatment
次要结局
- To assess patient perceptions of hair loss and hair regrowth in patients undergoing WBRT using VMAT via self assessment at intervals up to 16 weeks post end of treatment.(4 months post radiotherapy treatment end)
研究者
Lynsey RICE
Research and Development radiographer
HCA International Limited