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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330964
Recruitment Status : Unknown
Verified September 2017 by The First Affiliated Hospital of Dalian Medical University.
Recruitment status was:  Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Dalian Medical University

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.

Condition or disease Intervention/treatment Phase
Neurotoxicity Gastrointestinal Neoplasms Other: electro-acupuncture Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Parallel Control Study of Electroacupuncture Stimulation the Acupoints of Yangming Channel on Prevention and Treatment of Oxaliplatin Neurotoxicity During the Peri-chemotherapy Period
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Experimental: electroacupuncture group
The experimental group adopted chemotherapy combined with electro-acupuncture stimulated related acupoints for 3 days running.
Other: electro-acupuncture
Electroacupuncture was administrated immediately after completion of oxaliplatin infusion,once a day for 3 days,30 minutes each time.

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



Primary Outcome Measures :
  1. Levi sensory nerve toxicity classification standard [ Time Frame: every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months] ]
    Scoring scale


Secondary Outcome Measures :
  1. The quality of life questionnaire(QLQ)-C30 [ Time Frame: every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months] ]
    Scoring scale


Other Outcome Measures:
  1. National Cancer Institute(NCI)Common Toxicity Criteria [ Time Frame: every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months] ]
    Blood and Scoring scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330964


Contacts
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Contact: Xiaonan Cui, MD,PhD +8618098876725 cxn23@sina.com
Contact: Weiwei Zhang, MM +8613234062398 1650579799@qq.com

Locations
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China, Liaoning
Oncology Department,The First Affiliated Hospital of Dalian Medical University Recruiting
Dalian, Liaoning, China, 116011
Contact: Xiaonan Cui, MD,PhD    +8618098876725    cxn23@sina.com   
Contact: Weiwei Zhang, MM    +8613234062398    1650579799@qq.com   
The First Affiliated Hospital of Dalian Medical University Not yet recruiting
Dalian, Liaoning, China, 116011
Contact: Xiaonan Cu, MD,PhD    +8618098876725    cxn23@sina.com   
Contact: Weiwei Zhang, MM    +8613234062398    1650579799@qq.com   
Sponsors and Collaborators
The First Affiliated Hospital of Dalian Medical University
Investigators
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Principal Investigator: Xiaonan Cui, MD,PhD The First Affiliated Hospital of Dalian Medical University
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Responsible Party: The First Affiliated Hospital of Dalian Medical University
ClinicalTrials.gov Identifier: NCT03330964    
Other Study ID Numbers: YJ-KY-2017-102
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Neurotoxicity Syndromes
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases