Acupuncture for Pain Control in Patients With Inoperable Pancreatic Cancer

Pain Clinical Trial

Official title:

Electroacupuncture Analgesia in Patients With Inoperable Pancreatic Cancer: A Randomized, Sham-controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02333409
• Other study ID #: EA_CA pancreas
• Status: Terminated
• Phase: N/A
• Start date: March 2015
• Est. completion date: March 1, 2020

Study information

• Verified date: July 2020
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Pancreas
• Pain
• Pancreatic Neoplasms

Intervention

Procedure:
• Electroacupuncture
Electroacupuncture (EA) has been used as a part of Traditional Chinese Medicine (TCM) and the benefits and success of EA as a viable treatment option for acute and chronic pain of various origins have been well-recognised.electro-acupuncture (EA) is taken place as to give out the stimulation with fixed frequency, pulse width and current to acupuncture needle for further promotion of analgesics effects.

Locations

Country	Name	City	State
Hong Kong	Department of Surgery; The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain scores in numeric rating scale (NRS)	Pain Score	1 Month after Procedure
Secondary	Procedural discomfort	Discomfort feeling on visual analog scale (from 0 which implies no discomfort at all, to 100 which implies the worst discomfort imaginable)	Day 0 after procedure
Secondary	Willingness to repeat procedure	Patient's willingness to repeat the procedure	1 Month after Procedure
Secondary	Morbidities related to the procedures	Morbidities related to the procedures	1 Month after Procedure
Secondary	Quality of Life scores	Quality of Life	1 Month after Procedure