Chemotherapy-induced Nausea and VomitingNCT04785495
Prevalence of Anticipatory Nausea and Vomiting in Cancer Patients Exposed to Highly Emetogenic Chemotherapy
An observational study of Chemotherapy-induced Nausea and Vomiting, run by Instituto Brasileiro de Controle do Cancer at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Quality-of-life assessment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Aug 2020to Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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);
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Rafaela de Brito Alves
São Paulo, São Paulo, 03102-002
Felipe José Silva Melo Cruz, PhD, felipemcruz@yahoo.com.br
Rafaela de Brito Alves, MD
About this study
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.
Read the 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.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Quality-of-life assessment
- Keywords
- Nausea, Antiemetics, Antineoplastic, Quality of Life
- Medical subject headings
- Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-life assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anticipatory nausea and vomiting in cancer patients undergoing highly emetogenic chemotherapy regimen
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.
Measured: Baseline to 6 days after chemotherapy
Secondary outcomes (2)
Patient's daily diary
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.
Measured: 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)
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).
Measured: Days 1 (before starting chemotherapy) and 6 (after chemotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start12 Aug 2020
- Primary completionAug 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Brasileiro de Controle do Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafaela de Brito Alves, Instituto Brasileiro de Controle do Cancer
- Investigators
- Camilla Vieira de Rebouças, MD, Study chair, Instituto Brasileiro de Controle do CancerLouize Caroline Marques Oliveira, MD, Study chair, Instituto Brasileiro de Controle do CancerRafaela de Brito Alves, MD, Principal investigator, Instituto Brasileiro de Controle do Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785495
- Sponsor's protocol ID
- 32148820000000072
- Status last verified
- Dec 2020
- First submitted
- 1 Mar 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Anticipatory Nausea and Vomiting in Cancer Patients Exposed to Highly Emetogenic Chemotherapy
- ClinicalTrials.gov ID
- NCT04785495
- Acronym / sponsor ID
- 32148820000000072
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- Nausea, Antiemetics, Antineoplastic, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Instituto Brasileiro de Controle do CancerUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer Patients Exposed to Highly Emetogenic Chemotherapy | – | Other: Quality-of-life assessmentPatients who will start chemotherapy with a high-grade emetogenic scheme and who have received adequate antiemetic prophylaxis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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);
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality-of-life assessmentPatients 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. | Other | Cancer Patients Exposed to Highly Emetogenic Chemotherapy |
Primary outcome
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.
2 secondary outcomes
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)
Quality of life - Functional Living Index-Emesis (FLIE)
Time frame: Days 1 (before starting chemotherapy) and 6 (after chemotherapy)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camilla Vieira de Rebouças, MD study chair
Instituto Brasileiro de Controle do Cancer
Louize Caroline Marques Oliveira, MD study chair
Instituto Brasileiro de Controle do Cancer
Rafaela de Brito Alves, MD principal investigator
Instituto Brasileiro de Controle do Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Nausea and Vomiting, run by Instituto Brasileiro de Controle do Cancer at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rafaela de Brito Alves, MD (+5586999693738, rafaelabalves@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anticipatory nausea and vomiting in cancer patients undergoing highly emetogenic chemotherapy regimen (time frame: Baseline to 6 days after chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.