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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by zhu xiao yan, Fudan University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
zhu xiao yan, Fudan University Identifier:
First received: June 21, 2013
Last updated: July 9, 2013
Last verified: July 2013
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 Intervention Phase
Nausea Vomiting Metastatic Liver Cancer Device: acupoint electric stimulation Drug: tropisetron Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by zhu xiao yan, Fudan University:

Primary Outcome Measures:
  • Classification of nausea and vomiting [ Time Frame: 12 month ]

Secondary Outcome Measures:
  • The improvement of appetite [ Time Frame: 12 month ]

Estimated Enrollment: 74
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01895010

China, Shanghai
Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xiaoyan Zhu, Dotral    +08602164175590 ext 3625   
Principal Investigator: Xiaoyan Zhu, doc         
Sponsors and Collaborators
Fudan University
Principal Investigator: Xiaoyan Zhu, Doc Shanghai Cancer Centre, Fudan University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: zhu xiao yan, Attending doctor, Fudan University Identifier: NCT01895010     History of Changes
Other Study ID Numbers: ESA2013
Study First Received: June 21, 2013
Last Updated: July 9, 2013

Keywords provided by zhu xiao yan, Fudan University:
prevention and treatment
improvement of the patient's appetite

Additional relevant MeSH terms:
Liver Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on August 22, 2017