Palonosetron Associated to Aprepitant in Prophylaxis of PONV (PONV)

April 30, 2015 updated by: Instituto do Cancer do Estado de São Paulo

Evaluation of Palonosetron and Palonosetron/Aprepitant in Post Operative Nausea and Vomiting Incidence in Oncological Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Postoperative nausea and vomiting (PONV) is a common anesthetic complication that occurs in approximately 30% of the surgical population and can reach up to 70% in high risk patients for PONV. Advances have been made to prevent PONV, but the incidence is still high in certain groups of patients. In high risk patients, pharmacologic intervention should consist of multimodal therapy, targeting different mechanisms of action. 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. METHODS: this is a randomized and double blind clinical trial. Female high-risk patients for PONV(Apfel score 3 or 4) scheduled for mastectomy that agree with the study and signed the informed consent, are randomly distributed into one of two groups: Group A, aprepitant 80 mg per os one hour before the surgery and Group B will receive placebo by the same route one hour before surgery, in a blinded way. After induction of anesthesia, dexamethasone 4 mg and palonosetron 0,075mg are intravenously administered to all patients. After the end of the surgery, a patient-controlled analgesia (PCA) device will be intravenously inserted in all patients. In the postoperative period, patients will be evaluated for nausea, vomiting and pain intensity in the recovery room and after 24 hours

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • São Paulo
      • Sao Paulo, São Paulo, Brazil, 01403010
        • Recruiting
        • Angela Maria Sousa
        • Contact:
        • Sub-Investigator:
          • Thiago Grigio, MD
        • Principal Investigator:
          • angela sousa, phD
        • Sub-Investigator:
          • hazem ashmawi, phD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patients submitted to breast cancer surgery
  • non smokers

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aprepitant
patient will receive aprepitant 80 mg per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery
Drug: Aprepitant
aprepitant will be administered in preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively
Other Names:
  • Emend
Drug: Dexamethasone
Dexamethasone and plonosetron will be administered intraoperatively in both groups, durong surgery
Other Names:
  • Decadron
Placebo Comparator: placebo
patient will receive placebo per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery
Drug: Dexamethasone
Dexamethasone and plonosetron will be administered intraoperatively in both groups, durong surgery
Other Names:
  • Decadron
Drug: Placebo
Placebo will be administered in the preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of postoperative nausea and vomiting
Time Frame: 24 hours
intensity of nausea
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain measured by Verbal and descriptive scale
Time Frame: 24 hours
pain intensity in the first 24 hours after surgery
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cancer do Estado de São Paulo

Investigators

  • Study Director: Hazem A Ashmawi, phD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 31, 2015

First Submitted That Met QC Criteria

April 30, 2015

First Posted (Estimate)

May 1, 2015

Study Record Updates

Last Update Posted (Estimate)

May 1, 2015

Last Update Submitted That Met QC Criteria

April 30, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP297/12
  • 2012/11298-8 (Other Grant/Funding Number: FAPESP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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