Clinical trial NCT03627780: Genetic Polymorphism and Post Operative Nausea and Vomiting (PONV)
Official title: Genetic Polymorphism Associated With the Occurrence of Postoperative Vomiting and Vomiting (PONV) in Patients Undergoing Oncological Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genetic Predisposition to Disease
Postoperative Nausea
Polymorphism, Genetic
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2018-08-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: PONV (Post operative nausea and vomiting)
timeFrame: 24 hours
Secondary outcomes:
measure: Intensity of Acute Postoperative pain
timeFrame: 24 hours
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Cancer Institute of the State of Sao Paulo - ICESP
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Cancer Institute of the State of Sao Paulo
state: São Paulo
Study officials:
affiliation: Instituto do Cancer do Estado de São Paulo
name: Angela M Sousa, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.