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

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01895010
• Other study ID #: ESA2013
• Status: Recruiting
• Phase: Phase 2
• First received: June 21, 2013
• Last updated: July 9, 2013
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: July 2013
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Liver Neoplasms
• Metastatic Liver Cancer
• Nausea
• Vomiting

Intervention

Device:
• acupoint electric stimulation
acupoint electric stimulation combined with tropisetron 6mg before TACE

Drug:
• tropisetron
only tropisetron 6mg before TACE

Locations

Country	Name	City	State
China	Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Classification of nausea and vomiting		12 month	No
Secondary	The improvement of appetite		12 month	No