Gastrointestinal Neoplasms, Neurotoxicity
Conditions
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.
Interventions
OTHERelectro-acupuncture
Electroacupuncture was administrated immediately after completion of oxaliplatin infusion,once a day for 3 days,30 minutes each time.
Sponsors
The First Affiliated Hospital of Dalian Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| National Cancer Institute(NCI)Common Toxicity Criteria | every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months] | Blood and Scoring scale |
Countries
China
Contacts
Primary ContactXiaonan Cui, MD,PhD
Backup ContactWeiwei Zhang, MM
Outcome results
None listed