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

Sponsor

Fudan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01895010

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nausea Vomiting Metastatic Liver Cancer	Device: acupoint electric stimulation Drug: tropisetron	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jun 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acupoint and tropisetron acupoint electric stimulation combined with tropisetron 6mg before TACE	Device: acupoint electric stimulation acupoint electric stimulation combined with tropisetron 6mg before TACE
Active Comparator: tropisetron treated with tropisetron 6mg before TACE	Drug: tropisetron only tropisetron 6mg before TACE

Arm

Intervention/Treatment

Experimental: Acupoint and tropisetron

acupoint electric stimulation combined with tropisetron 6mg before TACE

Device: acupoint electric stimulation

acupoint electric stimulation combined with tropisetron 6mg before TACE

Active Comparator: tropisetron

treated with tropisetron 6mg before TACE

Drug: tropisetron

only tropisetron 6mg before TACE

Outcome Measures

Primary Outcome Measures

Classification of nausea and vomiting [12 month]

Secondary Outcome Measures

The improvement of appetite [12 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.