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

Not Applicable

• Conditions: Neurotoxicity; Gastrointestinal Neoplasms
• Interventions: Other: electro-acupuncture

• Registration Number: NCT03330964
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2017-09
• Study Start: 2017-09-01
• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2017-10-31
• Last Update Submitted: 2017-10-31
• Study First Posted: 2017-11-06
• Last Update Posted: 2017-11-06
• Primary Completion: 2018-03
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Levi sensory nerve toxicity classification standard	every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]	Scoring scale

Secondary Outcome Measures

Name	Time	Method
The quality of life questionnaire(QLQ)-C30	every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]	Scoring scale

Trial Locations

Locations (2)

The First Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China

Oncology Department，The First Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China