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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Parallel Control Study of Electroacupuncture Stimulation the Acupoints of Yangming Channel on Prevention and Treatment of Oxaliplatin Neurotoxicity During the Peri-chemotherapy Period

Conditions
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Neurotoxicity, Gastrointestinal Neoplasms

Intervention / Treatment
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* Other: electro-acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electroacupuncture group<br>The experimental group adopted chemotherapy combined with electro-acupuncture stimulated related acupoints for 3 days running. | Other: electro-acupuncture<br>* Electroacupuncture was administrated immediately after completion of oxaliplatin infusion,once a day for 3 days,30 minutes each time.<br>|
| No Intervention: control group<br>The control group received chemotherapy only(same as the experimental group),but no electroacupuncture treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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] |