Prevalence of Delayed Chemotherapy Associated Nausea

Chemotherapy-induced Nausea and Vomiting Clinical Trial

— CINrate  

Official title:

Delayed Chemotherapy-induced Nausea: A Multi-center Prevalence Survey in Adult Oncology Patients in Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342780
• Other study ID #: CINrate
• Status: Completed
• Start date: June 29, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: April 2024
• Source: St.Gallen University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates the prevalence of delayed chemotherapy induced nausea in adult oncology patients in real clinical practice of day clinics.

Description:

Chemotherapies are rated to have a high to minimal emetogenic potential in oncology patients. Their potential to induce delayed nausea is supposed to often be higher than their emetogenic potential. However, data on delayed chemotherapy-related nausea are scarce, which is problematic because nausea (a) has a large impact on patients quality of life and treatment decisions, (b) is often underestimated by health care professionals, (c) is less responsive to commonly used antiemetic medication, and (d) may even be different from rates that have been established in controlled clinical trials.

Therefore, the aim of this study is to assess the prevalence of delayed chemotherappy-induced nausea in adult oncology patients in dayclinics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• first day of chemotherapy of a new cycle (any cycle)

• speak and write German

• sign the consent forms

Exclusion Criteria:

• cognitive or linguistic impairments that would significantly impede consent or participation (as assessed by the nurses in charge)

• accompanying radiotherapy;

• pre-existing nausea within three days before the start of the first chemotherapy in this cycle; and

• prior participation in CINrate (each person participates only once)

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Locations

Country	Name	City	State
Switzerland	ZeTuP	St. Gallen

Sponsors (5)

Lead Sponsor	Collaborator
Antje Koller	Dr.-Hans-Altschüler-Stiftung, Spital Thurgau AG, University Medical Center Freiburg, ZETUP St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	delayed Nausea	nausea that occurs 24 hours to 5 days after chemotherapy (100mm VAS in diary)	Each patient: each days for 5 days after chemotherapy; recruitment: six weeks
Secondary	acute nausea	nausea that occurs within 24 hours of chemotherapy (100mm VAS in diary)	Each patient: at day of chemotherapy at discharge from dayclinic; recruitment: six weeks
Secondary	acute and delayed vomiting	vomiting that occurs within 5 days of chemotherapy (100mm VAS in diary)	Each patient: each day for 5 days after chemotherapy; recruitment: six weeks
Secondary	adherence to antiemetics	prescribed antiemetics compared with taken antiemetics; intake is calculated in % of the correct dose (dosing adherence) and in % of the dose at the right time (timing adherence)	Each patient: each day for 5 days after chemotherapy; recruitment: six weeks
Secondary	antiemetic prescription	antiemetic medication that is prescribed	Each patient: at day of chemotherapy at discharge from dayclinic; recruitment: six weeks
Secondary	interference of nausea or vomiting with everyday life	Functional Living Index Cancer (FLIE)	Each patient: measured at day 5 after chemotherapy; recruitment: six weeks
Secondary	patient-related barriers to antiemetics	Nausea and Vomiting Management Barriers Questionnaire (NVMBQ)	Each patient: measured at day 5 after chemotherapy; recruitment: six weeks