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

Phase 3

• Conditions: Pain; Pancreatic Cancer
• Interventions: Device: Acupuncture; Device: Placebo acupuncture

• Registration Number: NCT02510066
• Lead Sponsor: Shanghai Cancer Hospital, China

Brief Summary

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

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 Timeline

• Status Verified: 2015-07
• Study Start: 2015-07
• Study First Submitted: 2015-07-23
• Study First Submitted QC: 2015-07-27
• Last Update Submitted: 2015-07-27
• Study First Posted: 2015-07-28
• Last Update Posted: 2015-07-28
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	Acupuncture	Acupuncture participants would receive electroacupuncture on Jiaji (Ex-B2) points for 3 times in a week.
Placebo acupuncture	Placebo acupuncture	Placebo acupuncture participants would receive placebo acupuncture on non-point points for the same period.

Primary Outcome Measures

Name	Time	Method
Pain scores, assessed with numeric rating scale (NRS)	1 week

Secondary Outcome Measures

Name	Time	Method
Blood levels of β-endorphin	1 week
Karnofsky performance status (KPS) score	1 week
Blood levels of nerve growth factor	1 week

Trial Locations

Locations (1)

Shanghai Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China