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

Phase 2

• Conditions: Vomiting; Nausea; Metastatic Liver Cancer
• Interventions: Device: acupoint electric stimulation; Drug: tropisetron

• Registration Number: NCT01895010
• Lead Sponsor: Fudan University

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)

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-21
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-09
• Last Update Submitted: 2013-07-09
• Study First Posted: 2013-07-10
• Last Update Posted: 2013-07-10
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Acupoint and tropisetron	acupoint electric stimulation	acupoint electric stimulation combined with tropisetron 6mg before TACE
tropisetron	tropisetron	treated with tropisetron 6mg before TACE

Primary Outcome Measures

Name	Time	Method
Classification of nausea and vomiting	12 month

Secondary Outcome Measures

Name	Time	Method
The improvement of appetite	12 month

Trial Locations

Locations (1)

Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China