Electroacupuncture Analgesia in Patients With Inoperable Pancreatic Cancer: A Randomized, Sham-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- pain scores in numeric rating scale (NRS)
研究概览
简要总结
Pancreatic cancer is the sixth most common cause of cancer death in Hong Kong. Patients suffering from pancreatic cancer are associated with a poor prognosis and survival of less than one year is expected in inoperable tumours (1). Management of these patients would be towards palliation of symptoms. Severe pain occurs in 50 to 70% of the patients and this "intractable" pain is often difficult to treat (2). Pain management is a major part of the comprehensive therapy in patients with pancreatic cancer, and it also affects their quality of life. Electroacupuncture seems to be a promising way to control the cancer pain and reduce the dose and side effects of pain killers including opioid. This study aimed to investigate the efficacy and safety of electroacupuncture in reducing pancreatic cancer pain in patients suffering from inoperable pancreatic cancer.
详细描述
Patients suffering from pancreatic cancer are associated with a poor prognosis and survival of less than one year is expected in inoperable tumours. Management of these patients would be towards palliation of symptoms. Severe pain occurs in 50 to 70% of the patients and this "intractable" pain is often difficult to treat. Pain management is a major part of the comprehensive therapy in patients with pancreatic cancer, and it also affects their quality of life. Different pharmacological agents have been used in the past to control this pain and these include non-steroidal anti-inflammatory drugs and narcotic agents. However, these agents are associated with their own adverse effects and may further impair quality of life. Radiotherapy and celiac plexus neurolysis also can relieve the cancer pain, patients' responses are often variable and difficult to predict.
Recently, more and more studies were focused on the acupuncture for cancer pain. Electroacupuncture (EA) analgesia seems to be a promising way to control the cancer pain and reduce the dose and side effects of analgesics. The latest review in 2012 showed that acupuncture might be an effective analgesic adjunctive method for cancer pain after concluding the results of 15 randomized-control trials. Nevertheless, studies focused on patients with pancreatic cancer and results from randomized trials are lacking.
This study aims to investigate the efficacy and effectiveness of EA analgesia for patients with inoperable pancreatic cancer.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients ≥ 18 years old with cytology or histology confirmed pancreatic cancer
- •Abdominal pain typical for pancreatic cancer
- •Inoperability of pancreatic cancer as demonstrated by computed tomography (CT), positron emission tomography (PET) scan or endoscopic ultrasonography (EUS).
- •Informed consent available
排除标准
- •Patients who are allergic to the acupuncture needles
- •Coagulopathy (prolongation of prothrombin time > 18 sec, thrombocytopenia <80,000 platelets/ml)
- •Another cause for abdominal pain such as pseudocyst, ulcer or other intra-abdominal disorder
- •Had been treated by acupuncture for pancreatic cancer within 1 year
- •Potential patient noncompliance (refusing to follow schedule of events)
- •Active alcohol or other drug use or significant psychiatric illness
- •Expected survival less than 3 months
- •Unable to give informed consent
结局指标
主要结局
pain scores in numeric rating scale (NRS)
时间窗: 1 Month after Procedure
Pain Score
次要结局
- Quality of Life scores(1 Month after Procedure)
- Procedural discomfort(Day 0 after procedure)
- Morbidities related to the procedures(1 Month after Procedure)
- Willingness to repeat procedure(1 Month after Procedure)
研究者
Charing Chong, MD
Assistant Professor
Chinese University of Hong Kong