NeoplasmsNCT02116218
Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine
A study testing acupuncture and Vaccaria seed in people with Neoplasms and Pain, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
Pain control is a common and serious problem in cancer patients. Although WHO has developed a three-stage model of cancer pain management, 80% cancer patients still suffer moderate to severe pain in their daily life. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- What is being tested?
- acupuncture and Vaccaria seed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2014to Dec 2014
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 to 75 years, either gender.
- Visit emergency department
- Chief complaint is pain.
- Diagnosed by oncologist with International Classification of Diseases 9th revision (ICD-9) code between 140.0 to 239.9.
Who cannot join
- Serious comorbid conditions (for example, life-threatening condition).
- Patients who cannot communicate reliably with the investigator or who are not likely to obey the instructions of the trial.
- Pregnancy status.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine (TCM): A Study Protocol for a Clinical Trial
Pain control is a common and serious problem in cancer patients. Although WHO has developed a three-stage model of cancer pain management, 80% cancer patients still suffer moderate to severe pain in their daily life. When patients are with acute exacerbation or aggravate of pain, they usually visit the emergency department for more help.
Acupuncture is a safe, low-invasive and economic treatment. And it has been world-wide used as a complementary therapy among patients with cancer. It can not only relieve pain in cancer patients, but also can reduce some of the side effects caused by some treatment.
This study is aimed to evaluate the efficacy and safety of acupuncture in cancer patient with acute pain onset through emergency department with objective Traditional Chinese Medicine assessment.
- Being tested
- acupuncture, Vaccaria seed
- Keywords
- Traditional Chinese Medicine, acupuncture, complementary alternative medicine, cancer pain, emergency department
- Medical subject headings
- Neoplasms, Pain, Cancer Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
Acupuncture in the Hegu (LI4), Shousanli (LI10), Zusanli (ST36), Yanlinquan (GB34), Taichong (LV3) and Ouch point. Needles would be correctly inserted and manually stimulated until the 'De Qi' sensation is elicited. The needles would stay in place for 15 minutes.
Vaccaria seedProcedure or surgery
We put Vaccaria seeds near the acupoints without acupressure as an intervention in control group.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture | Experimental | Experimental group would receive acupuncture at specific acupoints for 15 minutes. Receives: Procedure: acupuncture |
| seed | Sham comparator | Control group would receive another intervention that we would put Vaccaria seeds near the acupoints but without acupressure for the same period. Receives: Procedure: Vaccaria seed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
The Visual Analog Scale (VAS) has proven its usefulness and its clinical validity for the evaluation of pain. VAS would be measured and compared before and after intervention.
Measured: 15 minutes after intervention
Heart rate variability
Autonomic nervous dysfunction plays a role as a consequence of pain. Recording the heart rate variability (HRV) in an easy non-invasive methods to investigate autonomic balance.
HRV would be measured and compared before and after intervention
Measured: 15 minutes after intervention
Secondary outcomes (3)
Tongue diagnosis
Tongue diagnosis plays an important role in TCM. In clinical practice Practitioners observed tongue characteristics, such as the color and shape, and the amount of saliva before deducing the primary ailment of a patient.
We would take photos of tongue before and after intervention to compare the clinical changes.
Measured: 15 minutes after intervention
Brief Pain Inventory
Brief Pain Inventory (BPI) was made by Pain Research Group in order to measure the pain score of cancer patients.
We would do the questionnaire before and 7 days after intervention to investigate if there's a long-term effect.
Measured: 7 days after intervention
adverse event
Participants should report any adverse events they experience, Including discomfort or bruising at the sites of needle insertion, nausea, or feeling faint after treatment.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: The study was terminated and the PI has left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lun-Chien Lo, Study chair, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116218
- Sponsor's protocol ID
- TCM-2014-ED
- Status last verified
- Feb 2020
- First submitted
- 10 Apr 2014
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Garcia MK, McQuade J, Haddad R, Patel S, Lee R, Yang P, Palmer JL, Cohen L. Systematic review of acupuncture in cancer care: a synthesis of the evidence. J Clin Oncol. 2013 Mar 1;31(7):952-60. doi: 10.1200/JCO.2012.43.5818. Epub 2013 Jan 22.
PubMed 23341529Chiu J, Yau T, Epstein RJ. Complications of traditional Chinese/herbal medicines (TCM)--a guide for perplexed oncologists and other cancer caregivers. Support Care Cancer. 2009 Mar;17(3):231-40. doi: 10.1007/s00520-008-0526-x. Epub 2008 Nov 14.
PubMed 19009311van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, Schouten HC, van Kleef M, Patijn J. Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Ann Oncol. 2007 Sep;18(9):1437-49. doi: 10.1093/annonc/mdm056. Epub 2007 Mar 12.
PubMed 17355955Azevedo Sao Leao Ferreira K, Kimura M, Jacobsen Teixeira M. The WHO analgesic ladder for cancer pain control, twenty years of use. How much pain relief does one get from using it? Support Care Cancer. 2006 Nov;14(11):1086-93. doi: 10.1007/s00520-006-0086-x. Epub 2006 Jun 8.
PubMed 16761128
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine (TCM): A Study Protocol for a Clinical Trial
- ClinicalTrials.gov ID
- NCT02116218
- Acronym / sponsor ID
- TCM-2014-ED
- Keywords
- Traditional Chinese Medicine, acupuncture, complementary alternative medicine, cancer pain, emergency department
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was terminated and the PI has left the institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Apr 2014 (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.
Pain control is a common and serious problem in cancer patients. Although WHO has developed a three-stage model of cancer pain management, 80% cancer patients still suffer moderate to severe pain in their daily life. When patients are with acute exacerbation or aggravate of pain, they usually visit the emergency department for more help.
Acupuncture is a safe, low-invasive and economic treatment. And it has been world-wide used as a complementary therapy among patients with cancer. It can not only relieve pain in cancer patients, but also can reduce some of the side effects caused by some treatment.
This study is aimed to evaluate the efficacy and safety of acupuncture in cancer patient with acute pain onset through emergency department with objective Traditional Chinese Medicine assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Experimental | Procedure: acupunctureExperimental group would receive acupuncture at specific acupoints for 15 minutes. |
| seed | Sham comparator | Procedure: Vaccaria seedControl group would receive another intervention that we would put Vaccaria seeds near the acupoints but without acupressure for the same period. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20 to 75 years, either gender.
- Visit emergency department
- Chief complaint is pain.
- Diagnosed by oncologist with International Classification of Diseases 9th revision (ICD-9) code between 140.0 to 239.9.
Key exclusion criteria (3 listed)
- Serious comorbid conditions (for example, life-threatening condition).
- Patients who cannot communicate reliably with the investigator or who are not likely to obey the instructions of the trial.
- Pregnancy status.
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 |
|---|---|---|
| acupunctureAcupuncture in the Hegu (LI4), Shousanli (LI10), Zusanli (ST36), Yanlinquan (GB34), Taichong (LV3) and Ouch point. Needles would be correctly inserted and manually stimulated until the 'De Qi' sensation is elicited. The needles would stay in place for 15 minutes. | Procedure or surgery | acupuncture |
| Vaccaria seedWe put Vaccaria seeds near the acupoints without acupressure as an intervention in control group. | Procedure or surgery | seed |
Primary outcome
Visual Analog Scale
Time frame: 15 minutes after intervention
The Visual Analog Scale (VAS) has proven its usefulness and its clinical validity for the evaluation of pain. VAS would be measured and compared before and after intervention.
Heart rate variability
Time frame: 15 minutes after intervention
Autonomic nervous dysfunction plays a role as a consequence of pain. Recording the heart rate variability (HRV) in an easy non-invasive methods to investigate autonomic balance. HRV would be measured and compared before and after intervention
3 secondary outcomes
Tongue diagnosis
Time frame: 15 minutes after intervention
Brief Pain Inventory
Time frame: 7 days after intervention
adverse event
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 hours.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Background: PubMed 23341529Garcia MK, McQuade J, Haddad R, Patel S, Lee R, Yang P, Palmer JL, Cohen L. Systematic review of acupuncture in cancer care: a synthesis of the evidence. J Clin Oncol. 2013 Mar 1;31(7):952-60. doi: 10.1200/JCO.2012.43.5818. Epub 2013 Jan 22.
- Background: PubMed 19009311Chiu J, Yau T, Epstein RJ. Complications of traditional Chinese/herbal medicines (TCM)--a guide for perplexed oncologists and other cancer caregivers. Support Care Cancer. 2009 Mar;17(3):231-40. doi: 10.1007/s00520-008-0526-x. Epub 2008 Nov 14.
- Background: PubMed 17355955van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, Schouten HC, van Kleef M, Patijn J. Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Ann Oncol. 2007 Sep;18(9):1437-49. doi: 10.1093/annonc/mdm056. Epub 2007 Mar 12.
- Background: PubMed 16761128Azevedo Sao Leao Ferreira K, Kimura M, Jacobsen Teixeira M. The WHO analgesic ladder for cancer pain control, twenty years of use. How much pain relief does one get from using it? Support Care Cancer. 2006 Nov;14(11):1086-93. doi: 10.1007/s00520-006-0086-x. Epub 2006 Jun 8.
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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.
Lun-Chien Lo study chair
Changhua Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and Vaccaria seed in people with Neoplasms and Pain, run by Changhua Christian Hospital at 1 site in Taiwan.
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 3 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: withdrawn, as of the sponsor's last update on 17 Feb 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 Taiwan. 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 withdrawn before enrolling participants, so there are no results.
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?
Visual Analog Scale (time frame: 15 minutes after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02116218, which also lists 4 linked publications.
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 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.