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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03330964
Other study ID # YJ-KY-2017-102
Secondary ID
Status Recruiting
Phase N/A
First received September 27, 2017
Last updated October 31, 2017
Start date September 1, 2017
Est. completion date May 2018

Study information

Verified date September 2017
Source The First Affiliated Hospital of Dalian Medical University
Contact Xiaonan Cui, MD,PhD
Phone +8618098876725
Email cxn23@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date May 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
China Oncology Department,The First Affiliated Hospital of Dalian Medical University Dalian Liaoning
China The First Affiliated Hospital of Dalian Medical University Dalian Liaoning

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other National Cancer Institute(NCI)Common Toxicity Criteria Blood and Scoring scale every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]
Primary Levi sensory nerve toxicity classification standard Scoring scale every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]
Secondary The quality of life questionnaire(QLQ)-C30 Scoring scale every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]
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