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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Fudan University
Sponsor:
Information provided by (Responsible Party):
zhu xiao yan, Fudan University
ClinicalTrials.gov Identifier:
NCT01895010
First received: June 21, 2013
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 Fudan University:

Primary Outcome Measures:
  • Classification of nausea and vomiting [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The improvement of appetite [ Time Frame: 12 month ] [ Designated as safety issue: No ]

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895010

Locations
China, Shanghai
Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xiaoyan Zhu, Dotral    +08602164175590 ext 3625    zhuxiaoyan@fudan.edu.cn   
Principal Investigator: Xiaoyan Zhu, doc         
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Xiaoyan Zhu, Doc Shanghai Cancer Centre, Fudan University
  More Information

No publications provided

Responsible Party: zhu xiao yan, Attending doctor, Fudan University
ClinicalTrials.gov Identifier: NCT01895010     History of Changes
Other Study ID Numbers: ESA2013
Study First Received: June 21, 2013
Last Updated: July 9, 2013
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
prevention and treatment
improvement of the patient's appetite
TACE

Additional relevant MeSH terms:
Nausea
Liver Neoplasms
Vomiting
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Tropisetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014