The Exploratory Study of Electroacupuncture in the Treatment of Peripheral Neuropathy Induced by Platinum Based Chemotherapy Drugs

NCT ID: NCT03048591

Last Updated: 2018-02-12

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-10

Study Completion Date

2018-11-01

Brief Summary

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Through the research to confirm the effectiveness and safety of using electroacupuncture in the treatment of chemotherapy-induced peripheral neuropathy.

Detailed Description

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Conditions

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Chemotherapy-induced Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Electroacupuncture group

Group Type EXPERIMENTAL

electroacupuncture

Intervention Type DEVICE

Acupoint selection: Bilateral Hegu (LI4), Qu-chi (LI1) of upper limbs and bilateral Zusanli (ST36) ,Taichung (LR3)of lower limbs.

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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electroacupuncture

Acupoint selection: Bilateral Hegu (LI4), Qu-chi (LI1) of upper limbs and bilateral Zusanli (ST36) ,Taichung (LR3)of lower limbs.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. The histopathological and / or cellular pathology results prove malignancy of the tumor and the patient has received chemotherapy treatment before.
2. 15weeks after the completion of chemotherapy, the limbs are still feeling abnormal and the symptoms fulfill World Health Organization (WHO) grade 2 or more.
3. zubrod - Eastern Cooperative Oncology Group-WHO (ZPS) grade 0-2, cardiac function, liver function and renal function are not significantly abnormal, the survival period of the patient is expected to be more than 6 months.
4. Gender unrestricted, aged between 18 to 80 years old.
5. Voluntary participation in the study, will to sign informed consent, willing to comply with randomized grouping, will to follow-up.

Exclusion Criteria

1. Patients who suffer from peripheral neuropathy due to infection, radiotherapy, HIV, chronic alcoholism, hypothyroidism, diabetes, paraneoplastic syndrome or other diseases; or are suffering from nervous system diseases.
2. Patients who are being treated with other drugs that may lead to neurotoxicity .
3. Patients with blood coagulation disorder.
4. Pregnancy and lactating women.
5. Patients with infection, scarring or defects near the acupoint sites.
6. Received intervention for the prevention and treatment of peripheral neuropathy 2 weeks before screening or has received traditional Chinese medicine (acupuncture, moxibustion, cupping, Chinese medicine therapy one month before.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bin Wang

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Central Contacts

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Bin Wang

Role: CONTACT

+8613820156627

Other Identifiers

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E2016014A

Identifier Type: -

Identifier Source: org_study_id

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