Clinical Trial of Electroacupuncture Stimulation on Preve... | NCT03330964

Studies
Clinical Trial of Electroacupuncture Stimulation on Prevention and Treatment of Oxaliplatin Neurotoxicity

NCT03330964

Sponsor

The First Affiliated Hospital of Dalian Medical University

Status

Unknown status

Last Update Posted

Nov 6, 2017Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Neurotoxicity
Gastrointestinal Neoplasms

Interventions

electro-acupuncture

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Mar 2018Estimated

Completion Date

May 2018Estimated

First Submitted Date

Sep 27, 2017

First Submission Date that Met QC Criteria

Oct 31, 2017

First Posted Date

Nov 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2017

Last Update Posted Date

Nov 6, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The clinical trail of electroacupuncture combined with oxaliplatin regimen on gastrointestinal carcinoma.This trail is randomized controled.Patients are diagnosed gastrointestinal cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive Oxaliplatin regimen.The treatment group receives electroacupuncture in addition to the chemotherapy.The control group only receive the same chemotherapy with the treatment group.Both group have the same adjuvant therapy.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
electroacupuncture group	Experimental	The experimental group adopted chemotherapy combined with electro-acupuncture stimulated related acupoints for 3 days running.	Other: electro-acupuncture
control group	No Intervention	The control group received chemotherapy only(same as the experimental group),but no electroacupuncture treatment.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
electro-acupuncture	Other	Electroacupuncture was administrated immediately after completion of oxaliplatin infusion,once a day for 3 days,30 minutes each time.	electroacupuncture group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Levi sensory nerve toxicity classification standard	Scoring scale	every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]

Secondary Outcomes

Measure	Description	Time Frame
The quality of life questionnaire(QLQ)-C30	Scoring scale	every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]

Other Outcomes

Measure	Description	Time Frame
National Cancer Institute(NCI)Common Toxicity Criteria	Blood and Scoring scale	every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age:18-80 ;
male and female ;
signed the informed consent form;
Eastern Cooperative oncology Group(ECOG)O-2,life expectancy more than 3 months;
Indication for Chemotherapy,no contraindication;
First time chemotherapy or at least 6 months after last chemotherapy and radiotherapy;
At least 8 weeks after last biotherapy;
Surgery:had not received transplantation surgery,at least 2 weeks after last major surgery.

Exclusion Criteria:

Chemotherapy is contraindicated;
Having the primary disease can cause the neuropathy;
A history of other malignant tumor in recent 5 years;
Less than 6 months after last chemotherapy or radiotherapy;
Less than 8 weeks after last biotherapy;
Being afraid of acupuncture seriously;
Had received transplantation surgery,less than 2 weeks after last major surgery;
Other researchers think is not suitable for this clinical trail.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaonan Cui, MD,PhD	Contact	+8618098876725		cxn23@sina.com
Weiwei Zhang, MM	Contact	+8613234062398		1650579799@qq.com

Overall Officials

Name	Affiliation	Role
Xiaonan Cui, MD,PhD	The First Affiliated Hospital of Dalian Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oncology Department，The First Affiliated Hospital of Dalian Medical University	Recruiting	Dalian	Liaoning	116011	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Undecided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020258	Neurotoxicity Syndromes
D005770	Gastrointestinal Neoplasms

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D011041	Poisoning
D064419	Chemically-Induced Disorders
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided