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Acupuncture for Pain Control in Patients With Inoperable Pancreatic Cancer

Primary Purpose

Cancer of Pancreas, Pain

Status
Terminated
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Electroacupuncture
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Pancreas focused on measuring Cancer of pancreas, Acupuncture, Pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Surgery; The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Electroacupuncture

Sham

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

pain scores in numeric rating scale (NRS)
Pain Score

Secondary Outcome Measures

Procedural discomfort
Discomfort feeling on visual analog scale (from 0 which implies no discomfort at all, to 100 which implies the worst discomfort imaginable)
Willingness to repeat procedure
Patient's willingness to repeat the procedure
Morbidities related to the procedures
Morbidities related to the procedures
Quality of Life scores
Quality of Life

Full Information

First Posted
December 23, 2014
Last Updated
July 15, 2020
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02333409
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Expertise resigned
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Pancreas, Pain
Keywords
Cancer of pancreas, Acupuncture, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electroacupuncture
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Electroacupuncture
Other Intervention Name(s)
Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain scores in numeric rating scale (NRS)
Description
Pain Score
Time Frame
1 Month after Procedure
Secondary Outcome Measure Information:
Title
Procedural discomfort
Description
Discomfort feeling on visual analog scale (from 0 which implies no discomfort at all, to 100 which implies the worst discomfort imaginable)
Time Frame
Day 0 after procedure
Title
Willingness to repeat procedure
Description
Patient's willingness to repeat the procedure
Time Frame
1 Month after Procedure
Title
Morbidities related to the procedures
Description
Morbidities related to the procedures
Time Frame
1 Month after Procedure
Title
Quality of Life scores
Description
Quality of Life
Time Frame
1 Month after Procedure

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Surgery; The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

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Acupuncture for Pain Control in Patients With Inoperable Pancreatic Cancer

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