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

NCT04785495 | Unknown DMC

• 1 other identifier: 32148820000000072
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chemotherapy-induced Nausea and Vomiting

Keywords

Nausea; Antiemetics; Antineoplastic; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient's daily diary

  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)

  Days 1 (before starting chemotherapy) and 6 (after chemotherapy)

Study Arms (1)

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.

Other: Quality-of-life assessment

Interventions

Quality-of-life assessment 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.

Cancer Patients Exposed to Highly Emetogenic Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Instituto Brasileiro de Controle do Cancer: lead

Study Sites (1)

Rafaela de Brito Alves

São Paulo, São Paulo, 03102-002, Brazil

RECRUITING

MeSH Terms

Conditions

Vomiting; Nausea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Camilla Vieira de Rebouças, MD

  Instituto Brasileiro de Controle do Cancer

  STUDY CHAIR

• Louize Caroline Marques Oliveira, MD

  Instituto Brasileiro de Controle do Cancer

  STUDY CHAIR

• Rafaela de Brito Alves, MD

  Instituto Brasileiro de Controle do Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafaela de Brito Alves, MD

CONTACT

+5586999693738; rafaelabalves@hotmail.com

Felipe José Silva Melo Cruz, PhD

CONTACT

+55 11 99446-6537; felipemcruz@yahoo.com.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 8, 2021
• Study Start: August 12, 2020
• Primary Completion: August 1, 2021
• Study Completion: November 1, 2021
• Last Updated: March 8, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)