A Multicenter, Prospective, Randomized Clinical Trial of the Clinical Effectiveness of Oncothermia Combined With Standard Chemotherapy in Metastatic Pancreatic Cancer Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ)-C30 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 a previous pilot study (NCT02150135), we found the improvement of quality of life, function, and symptom.
From this background, the investigators tried to show the effect of "Oncothermia" with conventional chemotherapy for pain control, increasing quality of life, and anti-tumor treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathologically confirmed pancreatic adenocarcinoma
- •Patients with radiologically identified metastasis (CT or MRI)
- •Patients with no history of previous chemotherapy
- •Patients with ECOG score 0-2
排除标准
- •Patients who have an experience of hyperthermia treatment
- •Patients who have a difficulty of sensing heat
- •Patients who have a skin graft or breast reconstruction surgery
- •Patients who have a cardiac pacemaker or an implanted metal
- •Pregnant or breast feeding women
- •Patients with uncontrolled infection, diabetes, hypertension, ischemic heart disease, myocardial infarct within 6 months
- •Patients who were treated with unproved drugs within 30 days
- •Patients who have a serious disease which can affect the person's safety
- •Patients who do not consent to the study
研究组 & 干预措施
Oncothermia
Patients with oncothermia treatment and palliative chemotherapy
干预措施: Oncothermia (Other)
Oncothermia
Patients with oncothermia treatment and palliative chemotherapy
干预措施: FOLFIRINOX or Gemcitabine based chemotherapy (Drug)
Control
Patients with palliative chemotherapy only
干预措施: FOLFIRINOX or Gemcitabine based chemotherapy (Drug)
结局指标
主要结局
European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ)-C30 score change
时间窗: 3 months
次要结局
- change of opioid use amount(3 months)
- Adverse effect(3 months)
- change of pain score (VAS score)(3 months)