Prevalence of Anticipatory Nausea and Vomiting in Cancer Patients Exposed to Highly Emetogenic Chemotherapy

NCT ID: NCT04785495

Last Updated: 2021-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-12

Study Completion Date

2021-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chemotherapy-induced Nausea and Vomiting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cancer Patients Exposed to Highly Emetogenic Chemotherapy

Patients who will start chemotherapy with a high-grade emetogenic scheme and who have received adequate antiemetic prophylaxis.

Quality-of-life assessment

Intervention Type OTHER

Patients will be provided the Functional Living Index - Emesis (FLIE) quality of life survey to be completed at time zero (before the application of chemotherapy) and then after 6 day, after application of chemotherapy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quality-of-life assessment

Patients will be provided the Functional Living Index - Emesis (FLIE) quality of life survey to be completed at time zero (before the application of chemotherapy) and then after 6 day, after application of chemotherapy.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Instituto Brasileiro de Controle do Cancer

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rafaela de Brito Alves

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Camilla Vieira de Rebouças, MD

Role: STUDY_CHAIR

Instituto Brasileiro de Controle do Cancer

Louize Caroline Marques Oliveira, MD

Role: STUDY_CHAIR

Instituto Brasileiro de Controle do Cancer

Rafaela de Brito Alves, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Brasileiro de Controle do Cancer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rafaela de Brito Alves

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rafaela de Brito Alves, MD

Role: CONTACT

+5586999693738

Felipe José Silva Melo Cruz, PhD

Role: CONTACT

+55 11 99446-6537

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Felipe José Silva Melo Cruz, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

32148820000000072

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.