Acupoint Electric Stimulation Combined With Tropisetron in Preventing and Treating Nausea and Vomiting After TACE

Study Overview
=================
Brief Summary
-----------------
Observation on acupoint electric stimulation combined with tropisetron in preventing and treating nausea and vomiting and improving the patient's appetite after TACE for primary or metastatic liver cancer patients.

Detailed Description
-----------------
Classification of nausea and vomiting, as measured by NCI CTC-AE version 3 The improvement of appetite, as measure by the classification of Appetite in accordance with NCI CTC-AE version 3. Quality of life: use M. D. Anderson symptom scale (the m. d. Anderson Symptom Inventory,MDASI)

Official Title
-----------------
Acupoint Electric Stimulation Combined With Tropisetron in Preventing and Treating Nausea and Vomiting After TACE

Conditions
-----------------
Nausea, Vomiting, Metastatic Liver Cancer

Intervention / Treatment
-----------------
* Device: acupoint electric stimulation
* Drug: tropisetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ECOG physical status 0,1,2 would accept the transcatheter hepatic arterial chemoembolization of primary or metastatic liver cancer patients; Adult male and female 3, age 18 years old; the chem-scheme of arterial infusion chemotherapy based on oxaliplatin dosage of 200mg; signed the informed consent and understand the study design; Organ function examination in patients must meet the following laboratory indexes: Neutrophil>500/Ul, hemoglobin > 8 gm/dL, platelet >100000/uL,Creatinine < 2 mg/dL bilirubin < 1.5 mg/dL, , alanine aminotransferase < 3 times the normal value, albumin >30g/L understand and complete quality of life scale ; women of childbearing age urine pregnancy test was negative. Exclusion Criteria: The combined use of other venous chemotherapy within 5 days after TACE; skin infection on or near the points; skin hyperalgesia, unable to withstand electrical stimulation; other confounding factors may cause nausea and vomiting (such as intestinal obstruction, anorexia, etc.); heart, cerebrovascular accident history or the history of spinal cord injury; intestinal obstruction lead to nausea and vomiting installing pacemaker; cognitive dysfunction, unable to finish Scale; currently using acupuncture therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupoint and tropisetron<br>acupoint electric stimulation combined with tropisetron 6mg before TACE | Device: acupoint electric stimulation<br>* acupoint electric stimulation combined with tropisetron 6mg before TACE<br>|
| Active Comparator: tropisetron<br>treated with tropisetron 6mg before TACE | Drug: tropisetron<br>* only tropisetron 6mg before TACE<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Classification of nausea and vomiting |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement of appetite |  | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevention and treatment, improvement of the patient's appetite, TACE