- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04785495
Prevalence of Anticipatory Nausea and Vomiting in Cancer Patients Exposed to Highly Emetogenic Chemotherapy
4. marts 2021 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
50
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Rafaela de Brito Alves, MD
- Telefonnummer: +5586999693738
- E-mail: rafaelabalves@hotmail.com
Undersøgelse Kontakt Backup
- Navn: Felipe José Silva Melo Cruz, PhD
- Telefonnummer: +55 11 99446-6537
- E-mail: felipemcruz@yahoo.com.br
Studiesteder
-
-
SP
-
São Paulo, SP, Brasilien, 03102-002
- Rekruttering
- Rafaela de Brito Alves
-
Kontakt:
- Felipe José Silva Melo Cruz, PhD
- E-mail: felipemcruz@yahoo.com.br
-
Ledende efterforsker:
- Rafaela de Brito Alves, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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;
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Prevalence of anticipatory nausea and vomiting in cancer patients undergoing highly emetogenic chemotherapy regimen
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Patient's daily diary
Tidsramme: 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)
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Camilla Vieira de Rebouças, MD, Instituto Brasileiro de Controle do Cancer
- Studiestol: Louize Caroline Marques Oliveira, MD, Instituto Brasileiro de Controle do Cancer
- Ledende efterforsker: Rafaela de Brito Alves, MD, Instituto Brasileiro de Controle do Cancer
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
12. august 2020
Primær færdiggørelse (Forventet)
1. august 2021
Studieafslutning (Forventet)
1. november 2021
Datoer for studieregistrering
Først indsendt
1. marts 2021
Først indsendt, der opfyldte QC-kriterier
4. marts 2021
Først opslået (Faktiske)
8. marts 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. marts 2021
Sidst verificeret
1. december 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 32148820000000072
Plan for individuelle deltagerdata (IPD)
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