Clinical trial NCT02333409: Acupuncture for Pain Control in Patients With Inoperable Pancreatic Cancer
Official title: Electroacupuncture Analgesia in Patients With Inoperable Pancreatic Cancer: A Randomized, Sham-controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer of Pancreas
Pain
Keywords: Cancer of pancreas
Acupuncture
Pain
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. All patients ≥ 18 years old with cytology or histology confirmed pancreatic cancer
2. Abdominal pain typical for pancreatic cancer
3. Inoperability of pancreatic cancer as demonstrated by computed tomography (CT), positron emission tomography (PET) scan or endoscopic ultrasonography (EUS).
4. Informed consent available

Exclusion Criteria:

1. Patients who are allergic to the acupuncture needles
2. Coagulopathy (prolongation of prothrombin time \> 18 sec, thrombocytopenia \<80,000 platelets/ml)
3. Another cause for abdominal pain such as pseudocyst, ulcer or other intra-abdominal disorder
4. Had been treated by acupuncture for pancreatic cancer within 1 year
5. Potential patient noncompliance (refusing to follow schedule of events)
6. Active alcohol or other drug use or significant psychiatric illness
7. Expected survival less than 3 months
8. Unable to give informed consent

Primary outcomes:
measure: pain scores in numeric rating scale (NRS)
timeFrame: 1 Month after Procedure
Secondary outcomes:
measure: Procedural discomfort
timeFrame: Day 0 after procedure
measure: Willingness to repeat procedure
timeFrame: 1 Month after Procedure
measure: Morbidities related to the procedures
timeFrame: 1 Month after Procedure
measure: Quality of Life scores
timeFrame: 1 Month after Procedure
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Surgery; The Chinese University of Hong Kong
Study officials:
References: