NCT02510066

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at below P25 for phase_3 pancreatic-cancer

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_3 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

1.9 years

First QC Date

July 23, 2015

Last Update Submit

July 27, 2015

Conditions

Pancreatic CancerPain

Keywords

Pancreatic CancerPainAcupuncture

Outcome Measures

Primary Outcomes (1)

  • Pain scores, assessed with numeric rating scale (NRS)

    1 week

Secondary Outcomes (3)

  • Karnofsky performance status (KPS) score

    1 week

  • Blood levels of β-endorphin

    1 week

  • Blood levels of nerve growth factor

    1 week

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Device: Acupuncture

Placebo acupuncture

PLACEBO COMPARATOR

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

Device: Placebo acupuncture

Interventions

AcupunctureDEVICE

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.

Also known as: Electroacupuncture
Acupuncture
Placebo acupunctureDEVICE

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.

Placebo acupuncture

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Pancreatic NeoplasmsPain

Interventions

Acupuncture TherapyElectroacupuncture

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsCombined Modality TherapyElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Hao Chen

    Shanghai Cancer Hospital

    STUDY CHAIR

Central Study Contacts

Hao Chen

CONTACT

86-13601996751chengkll@sina.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2015

First Posted

July 28, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

CN(1)