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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02510066
• Other study ID #: 12401905600
• Status: Recruiting
• Phase: Phase 3
• First received: July 23, 2015
• Last updated: July 27, 2015
• Start date: July 2015
• Est. completion date: June 2017

Study information

• Verified date: July 2015
• Source: Shanghai Cancer Hospital, China
• Contact: Hao Chen
• Phone: 86-13601996751
• Email: chengkll[@]sina.com
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Advanced pancreatic cancer at ?-? 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Shanghai Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Cancer Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores, assessed with numeric rating scale (NRS)		1 week	No
Secondary	Karnofsky performance status (KPS) score		1 week	No
Secondary	Blood levels of ß-endorphin		1 week	No
Secondary	Blood levels of nerve growth factor		1 week	No