Cancer of PancreasNCT02333409
Acupuncture for Pain Control in Patients With Inoperable Pancreatic Cancer
A study testing Electroacupuncture in people with Cancer of Pancreas and Pain, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer of Pancreas, Pain
- What is being tested?
- Electroacupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteHong Kong
- Study dates
- Mar 2015to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Surgery; The Chinese University of Hong Kong
Hong Kong
About this study
Official title: Electroacupuncture Analgesia in Patients With Inoperable Pancreatic Cancer: A Randomized, Sham-controlled Study
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.
Read the 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.
- Conditions
- Cancer of Pancreas, Pain
- Being tested
- Electroacupuncture
- Keywords
- Cancer of pancreas, Acupuncture, Pain
- Medical subject headings
- Pancreatic Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
Also called Acupuncture
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.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture | Active comparator | 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. Receives: Procedure: Electroacupuncture |
| Sham | Sham comparator | 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. Receives: Procedure: Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores in numeric rating scale (NRS)
Pain Score
Measured: 1 Month after Procedure
Secondary outcomes (4)
Procedural discomfort
Discomfort feeling on visual analog scale (from 0 which implies no discomfort at all, to 100 which implies the worst discomfort imaginable)
Measured: Day 0 after procedure
Willingness to repeat procedure
Patient's willingness to repeat the procedure
Measured: 1 Month after Procedure
Morbidities related to the procedures
Morbidities related to the procedures
Measured: 1 Month after Procedure
Quality of Life scores
Quality of Life
Measured: 1 Month after Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startMar 2015
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Why it stopped: Expertise resigned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of PancreasStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charing Chong, MD, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333409
- Sponsor's protocol ID
- EA_CA pancreas
- Status last verified
- Jul 2020
- First submitted
- 23 Dec 2014
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture Analgesia in Patients With Inoperable Pancreatic Cancer: A Randomized, Sham-controlled Study
- ClinicalTrials.gov ID
- NCT02333409
- Acronym / sponsor ID
- EA_CA pancreas
- Conditions
- Cancer of Pancreas, Pain
- Keywords
- Cancer of pancreas, Acupuncture, Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Expertise resigned
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture | Active comparator | Procedure: ElectroacupunctureA 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. |
| Sham | Sham comparator | Procedure: ElectroacupunctureFor 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureAlso: AcupunctureElectroacupuncture (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. | Procedure or surgery | Electroacupuncture, Sham |
Primary outcome
pain scores in numeric rating scale (NRS)
Time frame: 1 Month after Procedure
Pain Score
4 secondary outcomes
Procedural discomfort
Time frame: Day 0 after procedure
Willingness to repeat procedure
Time frame: 1 Month after Procedure
Morbidities related to the procedures
Time frame: 1 Month after Procedure
Quality of Life scores
Time frame: 1 Month after Procedure
Results and safety
The study was stopped early (reason given: Expertise resigned). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Cancer of Pancreas and Pain, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Expertise resigned). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain scores in numeric rating scale (NRS) (time frame: 1 Month after Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.