Back to results

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

Primary Purpose

Pancreatic Cancer, Pain

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Acupuncture

Placebo acupuncture

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Pain, Acupuncture

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Shanghai Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acupuncture

Placebo acupuncture

Arm Description

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.

Outcomes

Primary Outcome Measures

Pain scores, assessed with numeric rating scale (NRS)

Secondary Outcome Measures

Karnofsky performance status (KPS) score

Blood levels of β-endorphin

Blood levels of nerve growth factor

Full Information

NCT ID

NCT02510066

First Posted

July 23, 2015

Last Updated

July 27, 2015

Sponsor

Shanghai Cancer Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT02510066

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

July 2015 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Cancer Hospital, China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer, Pain

Keywords

Pancreatic Cancer, Pain, Acupuncture

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture

Arm Type

Experimental

Arm Description

Acupuncture participants would receive electroacupuncture on Jiaji (Ex-B2) points for 3 times in a week.

Arm Title

Placebo acupuncture

Arm Type

Placebo Comparator

Arm Description

Placebo acupuncture participants would receive placebo acupuncture on non-point points for the same period.

Intervention Type

Device

Intervention Name(s)

Acupuncture

Other Intervention Name(s)

Electroacupuncture

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Placebo acupuncture

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pain scores, assessed with numeric rating scale (NRS)

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Karnofsky performance status (KPS) score

Time Frame

1 week

Title

Blood levels of β-endorphin

Time Frame

1 week

Title

Blood levels of nerve growth factor

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hao Chen

Phone

86-13601996751

chengkll@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hao Chen

Organizational Affiliation

Shanghai Cancer Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Shanghai Cancer Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hao Chen

Phone

86-13601996751

chengkll@sina.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs