Clinical trial NCT01895010: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nausea
Vomiting
Metastatic Liver Cancer
Keywords: prevention and treatment
improvement of the patient's appetite
TACE
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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)

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.

Primary outcomes:
measure: Classification of nausea and vomiting
timeFrame: 12 month
Secondary outcomes:
measure: The improvement of appetite
timeFrame: 12 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Shanghai Cancer Centre, Fudan University
name: Xiaoyan Zhu, Doc
role: PRINCIPAL_INVESTIGATOR
References:
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.