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

Study 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.

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

Conditions
-----------------
Pain, Pancreatic Cancer

Intervention / Treatment
-----------------
* Device: Acupuncture
* Device: Placebo acupuncture


Participation Criteria
=================
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 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>Acupuncture participants would receive electroacupuncture on Jiaji (Ex-B2) points for 3 times in a week. | Device: Acupuncture<br>* 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.<br>* Other names: Electroacupuncture;|
| Placebo Comparator: Placebo acupuncture<br>Placebo acupuncture participants would receive placebo acupuncture on non-point points for the same period. | Device: Placebo acupuncture<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatic Cancer, Pain, Acupuncture