- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02333409
Acupuncture for Pain Control in Patients With Inoperable Pancreatic Cancer
Electroacupuncture Analgesia in Patients With Inoperable Pancreatic Cancer: A Randomized, Sham-controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hong Kong, Hong Kong
- Department of Surgery; The Chinese University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Electroacupuncture
A Hong Kong registered Chinese Medicine practitioner will give Electroacupuncture treatments.
Patients will be treated in a comfortable prone position.
Jiaji (Ex-B2) points form T8 to T12 bilaterally are chosen based on traditional Chinese medicine (TCM) theory and neurophysiologic basis of Jiaji points.
After De Qi sensation is achieved, the handles of needles on homolateral T8-T12 Jiaji are respectively connected to the Han's acupoint nerve stimulator at a frequency of 2/100 Hz and a current of 1 mA with a disperse-dense waveform.
The needles remained for 30 min.
The treatment was given twice weekly on week 1 and week 3.
|
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.
Other Names:
|
Sham Comparator: Sham
For placebo acupuncture, sham placebo acupuncture needles (DongBang AcuPrime Acupuncture Inc., South Korea) will be used.
Its validity and credibility have been well demonstrated.
The needles with blunt tips are quickly put onto the same points used in the electroacupuncture group without inserting into the skin.
The needles on homolateral T8 and T12 Jiaji are then connected to the electric stimulator, but with zero frequency and electric current.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain scores in numeric rating scale (NRS)
Time Frame: 1 Month after Procedure
|
Pain Score
|
1 Month after Procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedural discomfort
Time Frame: Day 0 after procedure
|
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
|
Willingness to repeat procedure
Time Frame: 1 Month after Procedure
|
Patient's willingness to repeat the procedure
|
1 Month after Procedure
|
Morbidities related to the procedures
Time Frame: 1 Month after Procedure
|
Morbidities related to the procedures
|
1 Month after Procedure
|
Quality of Life scores
Time Frame: 1 Month after Procedure
|
Quality of Life
|
1 Month after Procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA_CA pancreas
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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