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

Overview

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

Full Title of Study: “Efficacy and Mechanisms of Acupuncture for Patients With Advanced Pancreatic Cancer Pain: : a Randomized, Placebo Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 2017

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Pain scores, assessed with numeric rating scale (NRS)
    • Time Frame: 1 week

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Cancer Hospital, China
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hao Chen, Study Chair, Shanghai Cancer Hospital
  • Overall Contact(s)
    • Hao Chen, 86-13601996751, chengkll@sina.com

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