NCT01895010

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 10, 2013

Status Verified

July 1, 2013

Enrollment Period

1.5 years

First QC Date

June 21, 2013

Last Update Submit

July 9, 2013

Conditions

NauseaVomitingMetastatic Liver Cancer

Keywords

prevention and treatmentimprovement of the patient's appetiteTACE

Outcome Measures

Primary Outcomes (1)

  • Classification of nausea and vomiting

    12 month

Secondary Outcomes (1)

  • The improvement of appetite

    12 month

Study Arms (2)

Acupoint and tropisetron

EXPERIMENTAL

acupoint electric stimulation combined with tropisetron 6mg before TACE

Device: acupoint electric stimulation

tropisetron

ACTIVE COMPARATOR

treated with tropisetron 6mg before TACE

Drug: tropisetron

Interventions

acupoint electric stimulationDEVICE

acupoint electric stimulation combined with tropisetron 6mg before TACE

Acupoint and tropisetron
tropisetronDRUG

only tropisetron 6mg before TACE

tropisetron

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28069044DERIVED

MeSH Terms

Conditions

NauseaVomitingLiver Neoplasms

Interventions

Tropisetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Xiaoyan Zhu, Doc

    Shanghai Cancer Centre, Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending doctor

Study Record Dates

First Submitted

June 21, 2013

First Posted

July 10, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 10, 2013

Record last verified: 2013-07

Locations

CN(1)