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

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
electroacupuncture
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Electroacupuncture group

    control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy (QLQ-CIPN20)

    Secondary Outcome Measures

    Functional Assessment of Cancer Treatment - General scale（FACT-G）

    Full Information

    First Posted
    February 7, 2017
    Last Updated
    February 8, 2018
    Sponsor
    Tianjin Medical University Cancer Institute and Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03048591
    Brief Title
    The Exploratory Study of Electroacupuncture in the Treatment of Peripheral Neuropathy Induced by Platinum Based Chemotherapy Drugs
    Official Title
    The Exploratory Study of Electroacupuncture in the Treatment of Peripheral Neuropathy Induced by Platinum Based Chemotherapy Drugs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 10, 2018 (Anticipated)
    Primary Completion Date
    September 1, 2018 (Anticipated)
    Study Completion Date
    November 1, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tianjin Medical University Cancer Institute and Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chemotherapy-induced Peripheral Neuropathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Electroacupuncture group
    Arm Type
    Experimental
    Arm Title
    control group
    Arm Type
    No Intervention
    Intervention Type
    Device
    Intervention Name(s)
    electroacupuncture
    Intervention Description
    Acupoint selection: Bilateral Hegu (LI4), Qu-chi (LI1) of upper limbs and bilateral Zusanli (ST36) ,Taichung (LR3)of lower limbs.
    Primary Outcome Measure Information:
    Title
    Quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy (QLQ-CIPN20)
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Functional Assessment of Cancer Treatment - General scale（FACT-G）
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The histopathological and / or cellular pathology results prove malignancy of the tumor and the patient has received chemotherapy treatment before. 15weeks after the completion of chemotherapy, the limbs are still feeling abnormal and the symptoms fulfill World Health Organization (WHO) grade 2 or more. 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. Gender unrestricted, aged between 18 to 80 years old. Voluntary participation in the study, will to sign informed consent, willing to comply with randomized grouping, will to follow-up. Exclusion Criteria: 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. Patients who are being treated with other drugs that may lead to neurotoxicity . Patients with blood coagulation disorder. Pregnancy and lactating women. Patients with infection, scarring or defects near the acupoint sites. 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bin Wang
    Phone
    +8613820156627
    Email
    wbin8888@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bin Wang
    Organizational Affiliation
    Tianjin Medical University Cancer Institute and Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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