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

Efficacy and Mechanisms of Acupuncture for Patients With Advanced Pancreatic Cancer Pain: : a Randomized, Placebo Controlled Trial

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

Study Overview

• Status: Unknown
• Conditions: Pain; Pancreatic Cancer
• Intervention / Treatment: Device: Acupuncture; Device: Placebo acupuncture

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Shanghai Cancer Hospital
      • Contact: Hao Chen; Phone Number: 86-13601996751; Email: chengkll@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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 and T12 Jiaji are respectively connected to the Han's acupoint nerve stimulator at a frequency of 2/100 Hz and a current of 1mA with a disperse-dense waveform for 30 minutes.; Other Names: Electroacupuncture
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 without inserting into the skin. The needles on homolateral points at the same level as T8 and T12 Jiaji are then connected to the electric stimulator, but with zero frequency and electric current.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Cancer Hospital, China
• Investigators: Study Chair: Hao Chen, Shanghai Cancer Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: July 23, 2015
• First Submitted That Met QC Criteria: July 27, 2015
• First Posted (Estimate): July 28, 2015

Study Record Updates

• Last Update Posted (Estimate): July 28, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Pain; Acupuncture; Pancreatic Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Cancer Pain
• Other Study ID Numbers: 12401905600