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Clinical Trials/NCT02510066
NCT02510066
Unknown
Phase 3

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

Shanghai Cancer Hospital, China1 site in 1 country62 target enrollmentJuly 2015

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Pancreatic Cancer
Sponsor
Shanghai Cancer Hospital, China
Enrollment
62
Locations
1
Primary Endpoint
Pain scores, assessed with numeric rating scale (NRS)
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
June 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai Cancer Hospital, China
Responsible Party
Sponsor

Eligibility Criteria

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
  • 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.

Outcomes

Primary Outcomes

Pain scores, assessed with numeric rating scale (NRS)

Time Frame: 1 week

Secondary Outcomes

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

Study Sites (1)

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