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

July 9, 2013 updated by: zhu xiao yan, Fudan University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Shanghai Cancer Center
        • Contact:
        • Principal Investigator:
          • Xiaoyan Zhu, doc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Classification of nausea and vomiting
Time Frame: 12 month
12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
The improvement of appetite
Time Frame: 12 month
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Xiaoyan Zhu, Doc, Shanghai Cancer Centre, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

June 21, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESA2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nausea

Clinical Trials on acupoint electric stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe