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

The First Affiliated Hospital of Dalian Medical University

Status: Unknown

Conditions: Gastrointestinal Neoplasms; Neurotoxicity

Treatments: Other: electro-acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03330964

YJ-KY-2017-102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 2 patient groups

electroacupuncture group

Experimental group

Description:

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

Treatment:

Other: electro-acupuncture

control group

No Intervention group

Description:

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