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

NCT ID: NCT03330964

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-05-31

Brief Summary

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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

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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.Mainly to study about oxaliplatin into electroacupuncture leads to the influence of the peripheral nerve toxicity.Other clinical evaluation includes chemotherapy drug toxicities,quality of life(QOL), etc.

Conditions

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Neurotoxicity Gastrointestinal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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electroacupuncture group

The experimental group adopted chemotherapy combined with electro-acupuncture stimulated related acupoints for 3 days running.

Group Type EXPERIMENTAL

electro-acupuncture

Intervention Type OTHER

Electroacupuncture was administrated immediately after completion of oxaliplatin infusion,once a day for 3 days,30 minutes each time.

control group

The control group received chemotherapy only(same as the experimental group),but no electroacupuncture treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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electro-acupuncture

Electroacupuncture was administrated immediately after completion of oxaliplatin infusion,once a day for 3 days,30 minutes each time.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaonan Cui, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Dalian Medical University

Locations

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Oncology Department，The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Xiaonan Cui, MD,PhD

Role: CONTACT

Phone: +8618098876725

Email: [email protected]

Weiwei Zhang, MM

Role: CONTACT

Phone: +8613234062398

Email: [email protected]

Facility Contacts

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Xiaonan Cui, MD,PhD

Role: primary

Weiwei Zhang, MM

Role: backup

Xiaonan Cu, MD,PhD

Role: primary

Weiwei Zhang, MM

Role: backup

Other Identifiers

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YJ-KY-2017-102

Identifier Type: -

Identifier Source: org_study_id