NCT02150135已完成1 期
Effect of Oncothermia on Improvement of Quality of Life in Unresectable Pancreatic Cancer Patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- ECOG score change
研究概览
简要总结
Patients with pancreatic cancer often suffer from pain. Because of such a pain, their quality of life have seriously deteriorated. There have been a few studies that showed an effect for pain control by hyperthermia (heating the patient's body). However, there are several limitations in conventional hyperthermia. In this study, the investigators tried to show the effect of "Oncothermia" which is more selective to malignant tissue than conventional hyperthermia for pain control, increasing quality of life, and anti-tumor treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inoperable or recurred pancreatic ductal adenocarcinoma
- •After the each cycle of chemotherapy, the disease status was "stable disease"
排除标准
- •Person who has an experience of hyperthermia treatment
- •Person who has a difficulty of sensing heat
- •Person who has a skin graft or breast reconstruction surgery
- •Person who has a cardiac pacemaker or an implanted metal
- •Pregnant or breast feeding women
- •Person with uncontrolled infection, diabetes, hypertension, ischemic heart disease, myocardial infarct within 6 months
- •Person who was treated with unproved drugs within 6 months
- •Person who have a serious disease which can affect the person's safety
- •Person who do not consent to the study
结局指标
主要结局
ECOG score change
时间窗: 3 months after oncothermia treatment
次要结局
- Progression free survival rate(3 months later after oncothermia treatment)
研究者
Jin-Hyeok Hwang
Professor
Seoul National University Hospital
研究点 (2)
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