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Trial record 1 of 23 for:    Pancreatic Cancer | ( Map: Hong Kong )
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Acupuncture for Pain Control in Patients With Inoperable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02333409
Recruitment Status : Recruiting
First Posted : January 7, 2015
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Charing Chong, MD, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Cancer of Pancreas Pain Procedure: Electroacupuncture Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Electroacupuncture Analgesia in Patients With Inoperable Pancreatic Cancer: A Randomized, Sham-controlled Study
Study Start Date : March 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020


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.
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.
Other Name: Acupuncture

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.
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.
Other Name: Acupuncture




Primary Outcome Measures :
  1. pain scores in numeric rating scale (NRS) [ Time Frame: 1 Month after Procedure ]
    Pain Score


Secondary Outcome Measures :
  1. 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)

  2. Willingness to repeat procedure [ Time Frame: 1 Month after Procedure ]
    Patient's willingness to repeat the procedure

  3. Morbidities related to the procedures [ Time Frame: 1 Month after Procedure ]
    Morbidities related to the procedures

  4. Quality of Life scores [ Time Frame: 1 Month after Procedure ]
    Quality of Life



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333409


Contacts
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Contact: Charing Chong 2632 2746 chongcn@surgery.cuhk.edu.hk
Contact: Daisy Feng 2632 2746 hfeng@surgery.cuhk.edu.hk

Locations
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Hong Kong
Department of Surgery; The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Charing C Chong, MBChB    852-26321496    Chongcn@surgery.cuhk.edu.hk   
Principal Investigator: Charing C Chong, MBChB         
Sponsors and Collaborators
Chinese University of Hong Kong

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Responsible Party: Charing Chong, MD, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02333409     History of Changes
Other Study ID Numbers: EA_CA pancreas
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Keywords provided by Charing Chong, MD, Chinese University of Hong Kong:
Cancer of pancreas
Acupuncture
Pain
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases