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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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