Efficacy And Mechanisms Of Acupuncture For Patients With Advanced Pancreatic Cancer Pain

Study Overview

Efficacy and Mechanisms of Acupuncture for Patients With Advanced Pancreatic Cancer Pain

This study compares the effect of acupuncture and placebo acupuncture on advanced pancreatic cancer pain and then investigates its potential mechanism of peripheral blood.

Acupuncture may alleviate abdominal or back pain of patients with advanced pancreatic cancer. Acupuncture participants would receive electroacupuncture on Jiaji (Ex-B2) points for 3 times in a week. Placebo acupuncture participants would receive placebo acupuncture on non-point points for the same period. Pain scores on numeric rating scale (NRS) and blood levels of β-endorphin and nerve growth factor are compared.

Pancreatic Cancer
Pain

DEVICE: Acupuncture
DEVICE: Placebo acupuncture

12401905600

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-07-23	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-07-27
First Submitted that Met QC Criteria 2015-07-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-07-28
First Posted (ESTIMATED) 2015-07-28	Results First Posted N/A	Last Verified 2015-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Acupuncture Acupuncture participants would receive electroacupuncture on Jiaji (Ex-B2) points for 3 times in a week.	DEVICE: Acupuncture Disposable stainless steel filiform needles (40mm in length and 0.30mm in diameter) are inserted perpendicularly into T8-T12 Jiaji (Ex-B2) points bilaterally to a depth of 25 mm. After De Qi sensation is achieved, the handles of needles on homolateral T8 DEVICE: Placebo acupuncture Placebo acupuncture needles (Dongbang AcuPrime Acupuncture Inc., South Korea) are used on the non-point points at the same level as T8 and T12 Jiaji, 4.5 cun lateral to the posterior median line. The needles with blunt tips are quickly put onto points wit
PLACEBO_COMPARATOR: Placebo acupuncture Placebo acupuncture participants would receive placebo acupuncture on non-point points for the same period.	DEVICE: Placebo acupuncture Placebo acupuncture needles (Dongbang AcuPrime Acupuncture Inc., South Korea) are used on the non-point points at the same level as T8 and T12 Jiaji, 4.5 cun lateral to the posterior median line. The needles with blunt tips are quickly put onto points wit

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Acupuncture

Acupuncture participants would receive electroacupuncture on Jiaji (Ex-B2) points for 3 times in a week.

DEVICE: Acupuncture

Disposable stainless steel filiform needles (40mm in length and 0.30mm in diameter) are inserted perpendicularly into T8-T12 Jiaji (Ex-B2) points bilaterally to a depth of 25 mm. After De Qi sensation is achieved, the handles of needles on homolateral T8

DEVICE: Placebo acupuncture

Placebo acupuncture needles (Dongbang AcuPrime Acupuncture Inc., South Korea) are used on the non-point points at the same level as T8 and T12 Jiaji, 4.5 cun lateral to the posterior median line. The needles with blunt tips are quickly put onto points wit

PLACEBO_COMPARATOR: Placebo acupuncture

Placebo acupuncture participants would receive placebo acupuncture on non-point points for the same period.

DEVICE: Placebo acupuncture

Placebo acupuncture needles (Dongbang AcuPrime Acupuncture Inc., South Korea) are used on the non-point points at the same level as T8 and T12 Jiaji, 4.5 cun lateral to the posterior median line. The needles with blunt tips are quickly put onto points wit

Primary Outcome Measures	Measure Description	Time Frame
Pain scores, assessed with numeric rating scale (NRS)		1 week

Secondary Outcome Measures	Measure Description	Time Frame
Karnofsky performance status (KPS) score		1 week
Blood levels of β-endorphin		1 week
Blood levels of nerve growth factor		1 week

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Hao Chen

Phone Number: 86-13601996751

Email: chengkll@sina.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Advanced pancreatic cancer at Ⅲ-Ⅳ stage diagnosed by histological/cytological examination.
Pain score of abdominal or back pain ≥3 on a numeric rating scale (NRS) graduated from 0 to 10.
Stable dose of analgesics at least 72 hours before randomization.
Expected survival time more than 1 month.

Another cause for abdominal or back pain (such as prolapse of lumbar intervertebral disc, ulcer or other intra-abdominal disorder).
Acupuncture treatment in the past.
Contraindications for the use of acupuncture (such as severe allergies, bleeding tendency, infectious dermatosis and ulcer or scar at points).
Unable to give informed consent.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Hao Chen, Shanghai Cancer Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record