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Acupoint Electric Stimulation Combined With Tropisetron in Preventing and Treating Nausea and Vomiting After TACE
Conditions
Nausea - Vomiting - Metastatic Liver Cancer
Conditions: official terms
Liver Neoplasms - Nausea - Vomiting
Conditions: Keywords
prevention and treatment, improvement of the patient's appetite, TACE
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Intervention
Name: acupoint electric stimulation
Type: Device
Name: tropisetron
Type: Drug
Overall Status
Recruiting
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)
- 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
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
- 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.
Location
Shanghai Cancer Center
Shanghai, Shanghai, China
Status: Recruiting
Contact: Xiaoyan Zhu, Dotral - +08602164175590 - zhuxiaoyan@fudan.edu.cn
Start Date
June 2013
Completion Date
December 2014
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page