Genetic Polymorphism and Post Operative Nausea and Vomiting (PONV)

NCT03627780 | Completed DMC

• 1 other identifier: NP1127/2017
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Genetic Predisposition to Disease; Postoperative Nausea; Polymorphism, Genetic

Outcome Measures

Primary Outcomes (1)

• PONV (Post operative nausea and vomiting)

  Incidence of early (6 hours) and late (24 h) nausea and vomiting

  24 hours

Secondary Outcomes (1)

• Intensity of Acute Postoperative pain

  24 hours

Study Arms (2)

PONV

Patients presenting with postoperative nausea and vomiting

Diagnostic Test: DNA extraction

no PONV

Patients not presenting with postoperative nausea and vomiting

Diagnostic Test: DNA extraction

Interventions

DNA extraction DIAGNOSTIC_TEST

DNA will be extracted from white cells

PONV; no PONV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (2)

Cancer Institute of the State of Sao Paulo - ICESP

São Paulo, São Paulo, 01403010, Brazil

Location

Cancer Institute of the State of Sao Paulo

São Paulo, São Paulo, 01403010, Brazil

Location

Related Publications (3)

• 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.

  PMID: 26012530 RESULT

• 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.

  PMID: 24578078 RESULT

• Grigio TR, Furuya TK, Slullitel A, Murillo Carrasco AG, Uno M, Alves MJF, Carmona MJC, Sugino S, Chammas R, Sousa AM. Clinical, ethnic and genetic risk factors associated with postoperative nausea and vomiting in patients undergoing cancer surgery: a case-control study. Am J Transl Res. 2025 Apr 15;17(4):3235-3246. doi: 10.62347/DGRM3907. eCollection 2025.

  PMID: 40385041 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Genetic Predisposition to Disease; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Angela M Sousa, phd

  Instituto do Cancer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 13, 2018
• Study Start: January 2, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: May 19, 2021

Record last verified: 2021-05

Locations

BR (2)