NCT02431286

Brief Summary

The objective of this study is to investigate if aprepitant in association with palonosetron and dexamethasone could reduce the incidence of PONV in high-risk patients for this symptom, undergoing cancer surgery mastectomies.

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
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2014

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

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 1, 2015

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

January 31, 2015

Last Update Submit

April 30, 2015

Conditions

Postoperative Nausea and Vomiting

Keywords

nausea and vomiting, postoperativeemesis, postoperative

Outcome Measures

Primary Outcomes (1)

  • incidence of postoperative nausea and vomiting

    intensity of nausea

    24 hours

Secondary Outcomes (1)

  • postoperative pain measured by Verbal and descriptive scale

    24 hours

Study Arms (2)

Aprepitant

EXPERIMENTAL

patient will receive aprepitant 80 mg per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery

Drug: AprepitantDrug: Dexamethasone

placebo

PLACEBO COMPARATOR

patient will receive placebo per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery

Drug: PlaceboDrug: Dexamethasone

Interventions

AprepitantDRUG

aprepitant will be administered in preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively

Also known as: Emend
Aprepitant
PlaceboDRUG

Placebo will be administered in the preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively

Also known as: Saline
placebo
DexamethasoneDRUG

Dexamethasone and plonosetron will be administered intraoperatively in both groups, durong surgery

Also known as: Decadron
Aprepitantplacebo

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients submitted to breast cancer surgery
  • non smokers

You may not qualify if:

  • any contraindication to one of the drugs
  • mental disease
  • inability to understand the method or refusal to participate in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angela Maria Sousa

São Paulo, São Paulo, 01403010, Brazil

RECRUITING

Related Publications (3)

  • Moon HY, Baek CW, Choi GJ, Shin HY, Kang H, Jung YH, Woo YC, Kim JY, Park SG. Palonosetron and aprepitant for the prevention of postoperative nausea and vomiting in patients indicated for laparoscopic gynaecologic surgery: a double-blind randomised trial. BMC Anesthesiol. 2014 Aug 10;14:68. doi: 10.1186/1471-2253-14-68. eCollection 2014.

    PMID: 25165427RESULT

  • George E, Hornuss C, Apfel CC. Neurokinin-1 and novel serotonin antagonists for postoperative and postdischarge nausea and vomiting. Curr Opin Anaesthesiol. 2010 Dec;23(6):714-21. doi: 10.1097/ACO.0b013e32833f9f7b.

    PMID: 20871394RESULT

  • Grigio TR, Sousa AM, Magalhaes GGN, Ashmawi HA, Vieira JE. Aprepitant plus palonosetron for the prevention of postoperative nausea and vomiting after breast cancer surgery: a double blind, randomized trial. Clinics (Sao Paulo). 2020;75:e1688. doi: 10.6061/clinics/2020/e1688. Epub 2020 Sep 2.

    PMID: 32901672DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

AprepitantSodium ChlorideDexamethasoneCalcium Dobesilate

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Hazem a Ashmawi, phD

    University of Sao Paulo

    STUDY DIRECTOR

Central Study Contacts

Angela Sousa, phD

CONTACT

551126616680angela.sousa@icesp.org.br

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2015

First Posted

May 1, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 1, 2015

Record last verified: 2015-04

Locations

BR(1)