Clinical trial NCT02116218: Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine
Official title: Assessment of Cancer Pain in Emergency Department in Traditional Chinese Medicine (TCM): A Study Protocol for a Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Neoplasms
Pain
Keywords: Traditional Chinese Medicine
acupuncture
complementary alternative medicine
cancer pain
emergency department
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 15 minutes after intervention
measure: Heart rate variability
timeFrame: 15 minutes after intervention
Secondary outcomes:
measure: Tongue diagnosis
timeFrame: 15 minutes after intervention
measure: Brief Pain Inventory
timeFrame: 7 days after intervention
measure: adverse event
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 hours.
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian hospital
Study officials:
affiliation: Changhua Christian Hospital
name: Lun-Chien Lo
role: STUDY_CHAIR
References:
citation: 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.
citation: Chiu 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.
citation: van 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.
citation: Azevedo 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.