- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04785495
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
Conditions
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
- Name: Rafaela de Brito Alves, MD
- Phone Number: +5586999693738
- Email: rafaelabalves@hotmail.com
Study Contact Backup
- Name: Felipe José Silva Melo Cruz, PhD
- Phone Number: +55 11 99446-6537
- Email: felipemcruz@yahoo.com.br
Study Locations
-
-
SP
-
São Paulo, SP, Brazil, 03102-002
- Recruiting
- Rafaela de Brito Alves
-
Contact:
- Felipe José Silva Melo Cruz, PhD
- Email: felipemcruz@yahoo.com.br
-
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
Keywords
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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