NCT03291561

Brief Summary

Evaluate the effect of perioperative electroacupuncture on rapid rehabilitation for the pancreatic cancer and periampullary carcinoma patients after operation .

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
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

2.4 years

First QC Date

July 30, 2017

Last Update Submit

September 21, 2017

Conditions

AcupunctureGastrointestinal Function

Outcome Measures

Primary Outcomes (4)

  • Gastrointestinal function score

    Using scale to evaluate the function of gastrointestinal tract after surgery

    day 1 after surgery

  • Gastrointestinal function score

    Using scale to evaluate the function of gastrointestinal tract after surgery

    day 3 after surgery

  • Gastrointestinal function score

    Using scale to evaluate the function of gastrointestinal tract after surgery

    day 5 after surgery

  • Gastrointestinal function score

    Using scale to evaluate the function of gastrointestinal tract after surgery

    day 7 after surgery

Secondary Outcomes (4)

  • Physical fitness index

    day 1 after surgery

  • Physical fitness index

    day 3 after surgery

  • Physical fitness index

    day 5 after surgery

  • Physical fitness index

    day 7 after surgery

Study Arms (2)

Electroacupuncture group

EXPERIMENTAL

Electroacupuncture Acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.

Procedure: Electroacupuncture

Sham electroacupuncture group

PLACEBO COMPARATOR

Sham acupuncture at Baihui, Nei guan, bilateral Zu, sanli and bilateral Tian shu.

Procedure: Sham electroacupuncture

Interventions

ElectroacupuncturePROCEDURE

Acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.

Electroacupuncture group
Sham electroacupuncturePROCEDURE

Sham acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.

Sham electroacupuncture group

Eligibility Criteria

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

You may qualify if:

  • gastric cancer with gastrectomy
  • less than 3 months life expectancy
  • voluntary and good compliance

You may not qualify if:

  • history of abdominal surgery, radiotherapy or chemotherapy
  • metastatic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 10021, China

RECRUITING

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Chengfeng Wang, B.A

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chengfeng Wang, B.A

CONTACT

861013811370062lifeofwater@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of pancreatic and gastric Surgery Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Record Dates

First Submitted

July 30, 2017

First Posted

September 25, 2017

Study Start

August 1, 2017

Primary Completion

January 1, 2020

Study Completion

December 31, 2020

Last Updated

September 25, 2017

Record last verified: 2017-09

Locations

CN(1)