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

Primary Purpose

Neurotoxicity, Gastrointestinal Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
electro-acupuncture
Sponsored by
The First Affiliated Hospital of Dalian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurotoxicity

Eligibility Criteria

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

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.

Sites / Locations

  • Oncology Department，The First Affiliated Hospital of Dalian Medical UniversityRecruiting
  • The First Affiliated Hospital of Dalian Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

electroacupuncture group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Levi sensory nerve toxicity classification standard
Scoring scale

Secondary Outcome Measures

The quality of life questionnaire(QLQ)-C30
Scoring scale

Full Information

First Posted
September 27, 2017
Last Updated
October 31, 2017
Sponsor
The First Affiliated Hospital of Dalian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03330964
Brief Title
Clinical Trial of Electroacupuncture Stimulation on Prevention and Treatment of Oxaliplatin Neurotoxicity
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Dalian Medical University

4. Oversight

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

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurotoxicity, Gastrointestinal Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
electroacupuncture group
Arm Type
Experimental
Arm Description
The experimental group adopted chemotherapy combined with electro-acupuncture stimulated related acupoints for 3 days running.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The control group received chemotherapy only(same as the experimental group),but no electroacupuncture treatment.
Intervention Type
Other
Intervention Name(s)
electro-acupuncture
Intervention Description
Electroacupuncture was administrated immediately after completion of oxaliplatin infusion,once a day for 3 days,30 minutes each time.
Primary Outcome Measure Information:
Title
Levi sensory nerve toxicity classification standard
Description
Scoring scale
Time Frame
every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]
Secondary Outcome Measure Information:
Title
The quality of life questionnaire(QLQ)-C30
Description
Scoring scale
Time Frame
every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]
Other Pre-specified Outcome Measures:
Title
National Cancer Institute(NCI)Common Toxicity Criteria
Description
Blood and Scoring scale
Time Frame
every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]

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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaonan Cui, MD,PhD
Phone
+8618098876725
Email
cxn23@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Weiwei Zhang, MM
Phone
+8613234062398
Email
1650579799@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaonan Cui, MD,PhD
Organizational Affiliation
The First Affiliated Hospital of Dalian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oncology Department，The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaonan Cui, MD,PhD
Phone
+8618098876725
Email
cxn23@sina.com
First Name & Middle Initial & Last Name & Degree
Weiwei Zhang, MM
Phone
+8613234062398
Email
1650579799@qq.com
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaonan Cu, MD,PhD
Phone
+8618098876725
Email
cxn23@sina.com
First Name & Middle Initial & Last Name & Degree
Weiwei Zhang, MM
Phone
+8613234062398
Email
1650579799@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided

Learn more about this trial

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

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