Gastrointestinal Neoplasms
Conditions
Brief summary
The clinical trail of Cinobufacini injection combined with Oxaliplatin regimen on gastrointestine 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 Cinobufotalin 20ml mixed with 5% Glucose injection 500ml from the first day of chemotherapy until seven days 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 of oxaliplatin into Cinobufacini injection leads to the influence of the peripheral nerve toxicity.Clinical evaluation includes neural electrophysiological test,chemotherapy drug toxicities,quality of life(QOL),etc.Blood biochemistry tests mainly include inflammatory cytokines,peroxidase reaction,immune cell number ratio and stress hormone,etc.
Interventions
cinobufacini injection 20ml mixed with 5% Glucose injection 500ml started at the first day of chemotherapy until seven days once a day.
DRUGchemotherapy
Chemotherapy is the oxaliplatin combination with fluorouracil regimen.
Sponsors
Xiaonan Cui
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age:18-70 * male and female * signed the informed consent form. * Diagnosis:Gastrointestinal cancer diagnosed by imaging,cell and pathology report. * 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. * Have 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. * Cinobufotalin allergy. * Had received transplantation surgery,less than 2 weeks after last major surgery. * Other researchers think is not suitable for this clinical trail.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| neural electrophysiological test | every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),up to 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| National Cancer Institute(NCI)Common Toxicity Criteria | every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months | — |
| Levi sensory nerve toxicity classification standard | every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months | — |
| image test | For adjuvant chemotherapy patients every 3 months.For saving chemotherapy patients every 2 months.anticipate up to 1 years. | — |
| The quality of life questionnaire(QLQ)-C30 | every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months | — |
| peroxidase reaction,in blood. | every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months | — |
| immune cell number ratio,in blood. | every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months | — |
| stress hormone,in blood. | every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months | Estradiol(Female),testosterone(male)etc,in bood. |
| inflammatory cytokines,in blood. | every cycle of chemotherapy(measure 6 cycles,each cycle is 21days),anticipate up to 5 months | For example:Interleukin(IL)-6,tumor necrosis factor(TNF)etc,in bood |
Countries
China
Contacts
Primary ContactXiaonan Cui, MD,PhD
Backup ContactRui Zhang
Outcome results
None listed