Efficacy Study of Acupuncture to Treat the Upper Abdominal Pain of Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Daegu Catholic University Medical Center
Sponsor:
Information provided by (Responsible Party):
Jin-Young, Chung, Daegu Catholic University Medical Center
ClinicalTrials.gov Identifier:
NCT01913574
First received: July 29, 2013
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

This study is to investigate the effectiveness of acupuncture for alleviating the upper abdominal pain of cancer patients


Condition Intervention Phase
Abdominal Pain
Device: Acupuncture
Procedure: Neurolytic celiac plexus block (NCPB)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Acupuncture to Alleviate the Upper Abdominal Pain of Cancer Patients Treated With Neurolytic Celiac Plexus Block

Resource links provided by NLM:


Further study details as provided by Daegu Catholic University Medical Center:

Primary Outcome Measures:
  • Visual analogue scale(VAS) [ Time Frame: Change from baseline to 2 weeks ] [ Designated as safety issue: No ]
    The patients will be required to document 100mm pain VAS, where '0' represents 'no pain' and '100', 'unbearable pain'. The change of pain will be reported by comparing the mean VAS before treatment, after 1 week, after 2 week, and 1 week follow-up.


Secondary Outcome Measures:
  • Analgesic drug consumption [ Time Frame: Change from baseline to 2 weeks ] [ Designated as safety issue: No ]
    Drug consumption per day will be documented before treatment, after 1 week, after 2 week, and 1 week follow-up.


Estimated Enrollment: 14
Study Start Date: March 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture & NCPB
The NCPB will be administered once at the start of the trial and the acupuncture will be performed 3 times per week for 2 weeks (6 times in total).
Device: Acupuncture
Acupuncture is applied three times a week for 20 minutes for 2 weeks (total 6 sessions). 9 Acupuncture points, CV12, CV13, P6, SP4, ST36(bilateral),LI4 (bilateral), LR3 (bilateral), ST34 (bilateral), and GB21(bilateral) are used, and CV12, CV13, ST36, and LR3 are electro-stimulated.
Procedure: Neurolytic celiac plexus block (NCPB)
An anaesthetic test is performed injecting 2ml mepivacaine. After assessing the efficacy and safety of this test, 10 ml of absolute alcohol is injected via each needle.
Active Comparator: NCPB
The NCPB alone will be applied to the patients in this group, once at the start of the trial.
Procedure: Neurolytic celiac plexus block (NCPB)
An anaesthetic test is performed injecting 2ml mepivacaine. After assessing the efficacy and safety of this test, 10 ml of absolute alcohol is injected via each needle.

Detailed Description:

Neurolytic celiac plexus block (NCPB) is a commonly performed procedure in patients with intractable pain due to malignancies involving the upper and mid abdomen. Recently, acupuncture is used as one of alternative interventions to treat cancer-related pains. This pilot study aims to investigate the effectiveness of pain-relief of acupuncture via comparing acupuncture plus NCPB with NCPB alone. Total 14 cancer patients with NCPB will be randomized into two groups of acupuncture and control.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 18 years
  • Upper abdominal pain VAS ≥ 5
  • Unresectable abdominal malignancy, moderate or severe abdominal pain poorly controlled with pharmacotherapy.
  • All patients had advanced cancer diagnosed by histological/cytological examination
  • Follow-up possible during the clinical trial
  • Written informed consent voluntarily

Exclusion Criteria:

  • Patient with uncorrectable coagulopathy
  • Patient with allergy to local anesthesics or alcohol..
  • Previous NCPB or had implanted epidural or intrathecal analgesic therapy
  • Inability to lie prone
  • Disease encasing the celiac plexus on computed Tomography scan
  • Patients with psychiatric diseases that could have affected the study assessments
  • Significant renal or hepatic disease
  • Inability to comprehend or express oneself in the Korean language
  • Refusal to participate in the trial or to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01913574

Contacts
Contact: Jin-Young Chung, M.D,Ph.D. +82 53 650 4505 jychung@cu.ac.kr

Locations
Korea, Republic of
Daegu Catholic University Medical Center Recruiting
Daegu, Kyungsangbukdo, Korea, Republic of
Sponsors and Collaborators
Daegu Catholic University Medical Center
Investigators
Principal Investigator: Jeong-Chul Seo, KMD, Ph.D Comprehensive and Integrative Medicine Institute
Principal Investigator: Min-Ah Gwak, KMD, Ph.D Daegu Oriental Hospital of Daegu Haany University
Principal Investigator: Seong_Hoon Park, KMD Comprehensive and Integrative Medicine Institute
  More Information

No publications provided

Responsible Party: Jin-Young, Chung, Department of anesthesiolgy, Daegu Catholic University Medical Center
ClinicalTrials.gov Identifier: NCT01913574     History of Changes
Other Study ID Numbers: CIMI-13-01-09
Study First Received: July 29, 2013
Last Updated: January 28, 2014
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on August 21, 2014