Genetic Polymorphism and Post Operative Nausea and Vomiting (PONV) (ponv)

Genetic Polymorphism Associated With the Occurrence of Postoperative Vomiting and Vomiting (PONV) in Patients Undergoing Oncological Surgeries

Nausea and vomiting affects 25-30% of individuals in the post-operative period and can reach more than 70-80% in high-risk patients. inherited factors may play a significant role in individual susceptibility and clinical research on hereditary factors involved in the pathogenesis of Postoperative nausea and vomiting (PONV) and chemotherapy nausea and vomiting (CINV) is relatively new. The aim of this study is to investigate whether inter-individual differences related to PONV are associated with genetic factors. 300 patients will be evaluated in postoperative oncological surgeries. The peripheral leukocyte DNA will be extracted by the Salting Out Procedure method and processed to genotyping for 48 SNPs from 15 candidate genes by real-time PCR by the Taqman method. The possible associations with demographic data and factors related to surgery will be analyzed by univariate and multivariate analysis.

Study Overview

• Status: Completed
• Conditions: Genetic Predisposition to Disease; Postoperative Nausea; Polymorphism, Genetic
• Intervention / Treatment: Diagnostic test: DNA extraction

Detailed Description

The aim of this study is to investigate whether inter-individual differences related to PONV are associated with genetic factors. 300 patients will be evaluated in postoperative oncological surgeries. The peripheral leukocyte DNA will be extracted by the Salting Out Procedure method and processed to genotyping for 48 single nucleotide polymorphisms (SNPs) from 15 candidate genes by real-time PCR by the Taqman method. The possible associations with demographic data and factors related to surgery will be analyzed by univariate and multivariate analysis.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Sao Paulo, São Paulo, Brazil, 01403010
      • Cancer Institute of the State of Sao Paulo - ICESP
    • Sao Paulo, São Paulo, Brazil, 01403010
      • Cancer Institute of the State of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

300 Patients submitted to cancer surgery, classified as high- and intermediate-risk for PONV according to Apfel Score, 150 cases and 150 controls.

Description

Inclusion Criteria:

• High and intermediate-risk patients for PONV (Apfel score 2, 3 and 4)

Exclusion Criteria:

• Low risk patients for PONV (Apfel score 0 and 1)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PONV; Patients presenting with postoperative nausea and vomiting	Diagnostic test: DNA extraction; DNA will be extracted from white cells
no PONV; Patients not presenting with postoperative nausea and vomiting	Diagnostic test: DNA extraction; DNA will be extracted from white cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PONV (Post operative nausea and vomiting)	Incidence of early (6 hours) and late (24 h) nausea and vomiting	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of Acute Postoperative pain	Intensity of Postoperative pain measures by numerical rate scale and descriptive scale will be assessed in the first 24 hours in all patients	24 hours

Collaborators and Investigators

• Sponsor: Instituto do Cancer do Estado de São Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Angela M Sousa, phd, Instituto do Cancer do Estado de Sao Paulo

Publications and helpful links

General Publications

• Hayase T, Sugino S, Moriya H, Yamakage M. TACR1 gene polymorphism and sex differences in postoperative nausea and vomiting. Anaesthesia. 2015 Oct;70(10):1148-59. doi: 10.1111/anae.13082. Epub 2015 May 27.
• Wesmiller SW, Bender CM, Sereika SM, Ahrendt G, Bonaventura M, Bovbjerg DH, Conley Y. Association between serotonin transport polymorphisms and postdischarge nausea and vomiting in women following breast cancer surgery. Oncol Nurs Forum. 2014 Mar 1;41(2):195-202. doi: 10.1188/14.ONF.195-202.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2017
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Signs and Symptoms, Digestive; Nausea; Vomiting; Disease Susceptibility; Postoperative Nausea and Vomiting; Genetic Predisposition to Disease
• Other Study ID Numbers: NP1127/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The researchers make a plan to share informations via Red Cap

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No