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Trial Title:
Acupoint Electric Stimulation Combined With Tropisetron in Preventing and Treating Nausea and Vomiting After TACE
NCT ID:
NCT01895010
Condition:
Nausea
Vomiting
Metastatic Liver Cancer
Conditions: Official terms:
Nausea
Vomiting
Tropisetron
Conditions: Keywords:
prevention and treatment
improvement of the patient's appetite
TACE
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
acupoint electric stimulation
Description:
acupoint electric stimulation combined with tropisetron 6mg before TACE
Arm group label:
Acupoint and tropisetron
Intervention type:
Drug
Intervention name:
tropisetron
Description:
only tropisetron 6mg before TACE
Arm group label:
tropisetron
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)
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoyan Zhu, Dotral
Phone:
+08602164175590
Phone ext:
3625
Email:
zhuxiaoyan@fudan.edu.cn
Investigator:
Last name:
Xiaoyan Zhu, doc
Email:
Principal Investigator
Start date:
June 2013
Completion date:
December 2014
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01895010
