Acupoint Electric Stimulation Combined With Tropisetron in Preventing and Treating Nausea and Vomiting After TACE

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Vomiting; Nausea; Metastatic Liver Cancer

Treatments: Device: acupoint electric stimulation; Drug: tropisetron

Study type: Interventional

Funder types: Other

Identifiers

NCT01895010

ESA2013

Details and patient eligibility

About

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.

Full 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)

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Acupoint and tropisetron

Experimental group

Description:

acupoint electric stimulation combined with tropisetron 6mg before TACE

Treatment:

Device: acupoint electric stimulation

tropisetron

Active Comparator group

Description:

treated with tropisetron 6mg before TACE

Treatment:

Drug: tropisetron