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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
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 21, 2013
Last Updated
July 9, 2013
Sponsor
Fudan University
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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
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Acupoint Electric Stimulation Combined With Tropisetron in Preventing and Treating Nausea and Vomiting After TACE

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