NCT03631004

Brief Summary

Olanzapine has been used as prophylactic antiemetic for chemotherapy induced nausea and vomiting. The project aims to evaluate the efficacy of olanzapine in combination with ondansetron and dexamethasone in patients at high risk of postoperative nausea and vomiting, with previous history of nausea and vomiting induced by prior chemotherapy, submitted to medium and large surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 11, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2021

Completed
Last Updated

January 13, 2022

Status Verified

December 1, 2021

Enrollment Period

2.4 years

First QC Date

August 11, 2018

Last Update Submit

January 11, 2022

Conditions

Postoperative NauseaPostoperative Nausea and Vomiting

Keywords

nausea and vomiting

Outcome Measures

Primary Outcomes (1)

  • incidence of postoperative nausea and vomiting

    nausea and vomiting/ retching (dichotomous variable)

    0-24 hours

Secondary Outcomes (17)

  • incidence of side effects

    0-6 hours

  • incidence of side effects

    0-24 hours

  • incidence of side effects

    24-48 hours

  • incidence of postoperative nausea and vomiting

    0-6 hours

  • incidence of postoperative nausea and vomiting

    24-48 hours

  • +12 more secondary outcomes

Study Arms (2)

olanzapine tablets

EXPERIMENTAL

PATIENT WILL TAKE OLANZAPINE 10 MG, 1 hour BEFORE SURGERY

Drug: Olanzapine

Starch tablets

PLACEBO COMPARATOR

PATIENT WILL TAKE PLACEBO 1 hour BEFORE SURGERY

Drug: Olanzapine

Interventions

OlanzapineDRUG

olanzapine 10 mg is given before surgery

Also known as: Treatment
Starch tabletsolanzapine tablets

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients submitted to medium and large surgeries in the thoracic or abdominal region (mastectomies, breast plastic, hysterectomies, annexectomies, gynecological pelvic surgeries, colectomies, rettosigmoidectomies) under general anesthesia
  • Patients aged between 18 and 60 years
  • Patients considered to be at high risk for PONV according to the Apfel scale (Apfel 3 or 4)
  • Patients with a history of chemotherapy-induced nausea and vomiting.

You may not qualify if:

  • Pregnancy or Lactation
  • Current use of typical anti-psychotic medications or atypical
  • History of allergy to olanzapine
  • Myocardial infarction or unstable angina in the 6 months prior to the day of surgery planning
  • History of severe ventricular arrhythmia (eg, VT or VF)
  • Heart Failure Class II or greater second NYHA
  • Postural hypotension or vasovagal syncope in the 6 months prior to the day of surgery planning
  • Narrow angle glaucoma
  • Parkinson's disease
  • Dementia
  • Inability to swallow medicines
  • QT interval history greater than 450ms or torsades de pointes
  • Patient does not want to participate in the study
  • Videolaparoscopy surgery
  • Contraindication for neuraxial block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute of the State of Sao Paulo - ICESP

São Paulo, São Paulo, 01403010, Brazil

Location

MeSH Terms

Conditions

Postoperative Nausea and VomitingNauseaVomiting

Interventions

OlanzapineTherapeutics

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Roger Chammas

    Instituto do Cancer do Estado de São Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2018

First Posted

August 15, 2018

Study Start

October 1, 2018

Primary Completion

February 10, 2021

Study Completion

February 10, 2021

Last Updated

January 13, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)