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

March 4, 2021 updated by: Rafaela de Brito Alves, Instituto Brasileiro de Controle do Cancer
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.

Study Overview

Status

Unknown

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • SP
      • São Paulo, SP, Brazil, 03102-002
        • Recruiting
        • Rafaela de Brito Alves
        • Contact:
        • Principal Investigator:
          • Rafaela de Brito Alves, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of anticipatory nausea and vomiting in cancer patients undergoing highly emetogenic chemotherapy regimen
Time Frame: Baseline to 6 days after chemotherapy
The prevalence of nausea and vomiting will be determined by the percentage of patients reporting the presence of a symptom at the assessment time point. Participants are asked to report any episodes of nausea and vomiting before (baseline) and up to 6 days after receiving chemotherapy. This result is measured during the first and second cycles of chemotherapy for each patient.
Baseline to 6 days after chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's daily diary
Time Frame: At the end of Cycle 1 up to the day of Cycle 2 (each cycle is 15 to 21 days)
Participants must record any episodes of nausea and vomiting in the diary. In addition, the patient must present a score for his symptom, from zero to ten (0 = no symptom / 10 = strong symptom) using the Visual Numerical Analog Scale.
At the end of Cycle 1 up to the day of Cycle 2 (each cycle is 15 to 21 days)
Quality of life - Functional Living Index-Emesis (FLIE)
Time Frame: Days 1 (before starting chemotherapy) and 6 (after chemotherapy)
The FLIE questionnaire will be completed on days 1 (before starting chemotherapy) and 6 (after chemotherapy). The FLIE questionnaire consists of a nausea domain and a vomiting domain of nine items each where the patient should rate how much nausea and vomiting have affected the quality of life. For each question the patient will rate how much nausea (or vomiting) has affected an aspect of his quality of life during the past five days. Each question uses a visual analogue scale (where 1= no emesis-7=a great deal).
Days 1 (before starting chemotherapy) and 6 (after chemotherapy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Camilla Vieira de Rebouças, MD, Instituto Brasileiro de Controle do Cancer
  • Study Chair: Louize Caroline Marques Oliveira, MD, Instituto Brasileiro de Controle do Cancer
  • Principal Investigator: Rafaela de Brito Alves, MD, Instituto Brasileiro de Controle do Cancer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2020

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32148820000000072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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