Acupoint Electric Stimulation Combined With Tropisetron in Preventing and Treating Nausea and Vomiting After TACE
Primary Purpose
Nausea, Vomiting, Metastatic Liver Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
acupoint electric stimulation
tropisetron
Sponsored by
About this trial
This is an interventional prevention trial for Nausea focused on measuring prevention and treatment, improvement of the patient's appetite, TACE
Eligibility 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.
Sites / Locations
- Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Acupoint and tropisetron
tropisetron
Arm Description
acupoint electric stimulation combined with tropisetron 6mg before TACE
treated with tropisetron 6mg before TACE
Outcomes
Primary Outcome Measures
Classification of nausea and vomiting
Secondary Outcome Measures
The improvement of appetite
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01895010
Brief Title
Acupoint Electric Stimulation Combined With Tropisetron in Preventing and Treating Nausea and Vomiting After TACE
Official Title
Acupoint Electric Stimulation Combined With Tropisetron in Preventing and Treating Nausea and Vomiting After TACE
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting, Metastatic Liver Cancer
Keywords
prevention and treatment, improvement of the patient's appetite, TACE
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupoint and tropisetron
Arm Type
Experimental
Arm Description
acupoint electric stimulation combined with tropisetron 6mg before TACE
Arm Title
tropisetron
Arm Type
Active Comparator
Arm Description
treated with tropisetron 6mg before TACE
Intervention Type
Device
Intervention Name(s)
acupoint electric stimulation
Intervention Description
acupoint electric stimulation combined with tropisetron 6mg before TACE
Intervention Type
Drug
Intervention Name(s)
tropisetron
Intervention Description
only tropisetron 6mg before TACE
Primary Outcome Measure Information:
Title
Classification of nausea and vomiting
Time Frame
12 month
Secondary Outcome Measure Information:
Title
The improvement of appetite
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoyan Zhu, Doc
Organizational Affiliation
Shanghai Cancer Centre, Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyan Zhu, Dotral
Phone
+08602164175590
Ext
3625
Email
zhuxiaoyan@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiaoyan Zhu, doc
12. IPD Sharing Statement
Citations:
PubMed Identifier
28069044
Citation
Xie J, Chen LH, Ning ZY, Zhang CY, Chen H, Chen Z, Meng ZQ, Zhu XY. Effect of transcutaneous electrical acupoint stimulation combined with palonosetron on chemotherapy-induced nausea and vomiting: a single-blind, randomized, controlled trial. Chin J Cancer. 2017 Jan 10;36(1):6. doi: 10.1186/s40880-016-0176-1.
Results Reference
derived
Learn more about this trial
Acupoint Electric Stimulation Combined With Tropisetron in Preventing and Treating Nausea and Vomiting After TACE
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