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

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04785495
• Other study ID #: 32148820000000072
• Status: Recruiting
• Start date: August 12, 2020
• Est. completion date: November 2021

Study information

• Verified date: December 2020
• Source: Instituto Brasileiro de Controle do Cancer
• Contact: Rafaela de Brito Alves, MD
• Phone: +5586999693738
• Email: rafaelabalves[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Brazil	Rafaela de Brito Alves	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Brasileiro de Controle do Cancer

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 6 days after chemotherapy
Secondary	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.	At the end of Cycle 1 up to the day of Cycle 2 (each cycle is 15 to 21 days)
Secondary	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).	Days 1 (before starting chemotherapy) and 6 (after chemotherapy)