Clinical trial NCT04785495: Prevalence of Anticipatory Nausea and Vomiting in Cancer Patients Exposed to Highly Emetogenic Chemotherapy
Official title: Prevalence of Anticipatory Nausea and Vomiting in Cancer Patients Exposed to Highly Emetogenic Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chemotherapy-induced Nausea and Vomiting
Keywords: Nausea
Antiemetics
Antineoplastic
Quality of Life
Lead sponsor: Instituto Brasileiro de Controle do Cancer
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is estimated to recruit a sample of 50 cancer patients, undergoing chemotherapy with high emetogenic grade regimens, at the reference hospital in São Paulo, Brazil.

Brief summary: Chemotherapy induced nausea and vomiting are common adverse events related to oncologic treatments. It can have deleterious effect on patients' quality of life and could lead to dose reductions and/or discontinuation of treatment. This study aims to quantify the prevalence of nausea and vomiting induced by highly emetogenic chemotherapy in patients who had adequate antiemetic prophylaxis, also to describe the epidemiologic profile and identify predisposing factors.

Detailed description: The investigators will track patients in the first and second cycles of chemotherapy. Information regarding comorbidities, medical history and sociodemographic characteristics will be collected. The impact of nausea and vomiting induced by the treatment on patient's quality of life will be evaluated using the questionnaire Functional Living Index-Emesis - FLIE.

Eligibility criteria: Inclusion Criteria:

* Patients with histological confirmation of cancer;
* Patients who will start chemotherapy with a high-grade emetogenic scheme and who have received adequate antiemetic prophylaxis;
* No previous cancer treatment for the current diagnosis (excluding surgery);

Exclusion Criteria:

* Patients who have an inability to answer the questionnaire, due to lack of discernment to answer the questions reliably;
* Patients who report vomiting during the 24 hours prior to the first cycle of chemotherapy treatment;
* Patients who have a disease or condition that could cause emesis (ie, metastasis in the central nervous system, gastrointestinal obstruction or metabolic and electrolyte imbalances);
* Patients using opioids or illicit drugs;
* Alcoholism;

Primary outcomes:
measure: Prevalence of anticipatory nausea and vomiting in cancer patients undergoing highly emetogenic chemotherapy regimen
timeFrame: Baseline to 6 days after chemotherapy
Secondary outcomes:
measure: Patient's daily diary
timeFrame: At the end of Cycle 1 up to the day of Cycle 2 (each cycle is 15 to 21 days)
measure: Quality of life - Functional Living Index-Emesis (FLIE)
timeFrame: Days 1 (before starting chemotherapy) and 6 (after chemotherapy)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Rafaela de Brito Alves
state: SP
Study officials:
affiliation: Instituto Brasileiro de Controle do Cancer
name: Camilla Vieira de Rebouças, MD
role: STUDY_CHAIR
affiliation: Instituto Brasileiro de Controle do Cancer
name: Louize Caroline Marques Oliveira, MD
role: STUDY_CHAIR
affiliation: Instituto Brasileiro de Controle do Cancer
name: Rafaela de Brito Alves, MD
role: PRINCIPAL_INVESTIGATOR
References: