Gastrointestinal Neoplasms Clinical Trial
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
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Dalian Medical University |
China,
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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