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临床试验/NCT01421316
NCT01421316终止2 期

Reducing Hair Loss With Volumetric Arc Therapy in Patients Treated With Whole Brain Radiotherapy: a Phase II Trial

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
2 期
状态
终止
入组人数
29
试验地点
1
主要终点
The European Organization for Research and Treatment of Cancer (EORTC)quality of life questionnaire (C15-PAL and BN20) measured at 1 month following treatment.

研究概览

简要总结

Up to 10% of patients with cancer will develop symptomatic brain metastases. Given this limited survival it is important to consider quality of life (QOL) when treating these patients. Whole brain radiotherapy (WBRT) can increase survival to 6 month. However, WBRT itself has been shown to reduce QOL by increasing drowsiness, leg weakness and hair loss in patients with brain metastases. Both fatigue and hair loss were reported to have the largest decline in QOL scores when WBRT is used in the prophylactic setting in small cell lung cancer. Recent technological improvements in patient positioning and treatment planning will allow us to treat the whole brain with reduced margins, allowing better sparing of the scalp. In view of the large impact of hair loss on quality of life, the investigators hypothesize to see an improved quality of life with scalp sparing techniques.

Study hypothesis: Volumetric arc therapy results in a reduced hair loss and a subsequent clinically important improvement in QOL.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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

入选标准

  • Brain metastases
  • Age ≥ 18 years.
  • Signed informed consent
  • Recursive Partitioning Analysis (RPA) class III patients
  • Recursive Partitioning Analysis (RPA) class I-II patients and >3 brain metastases
  • Patients with small cell lung cancer extended disease eligible for prophylactic Whole-Brain Radiotherapy (WBRT).

排除标准

  • Previous whole brain radiotherapy

结局指标

主要结局

The European Organization for Research and Treatment of Cancer (EORTC)quality of life questionnaire (C15-PAL and BN20) measured at 1 month following treatment.

时间窗: At 1 month.

Quality of life questionnaires are used.

次要结局

  • Hair quality before treatment and at 1 month following treatment.(at 1 month following treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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