Prevalence of Delayed Chemotherapy Associated Nausea

Completed

• Conditions: Chemotherapy-induced Nausea and Vomiting

• Registration Number: NCT04342780
• Lead Sponsor: Antje Koller

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-13
• Study Start: 2020-06-29
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
delayed Nausea	Each patient: each days for 5 days after chemotherapy; recruitment: six weeks	nausea that occurs 24 hours to 5 days after chemotherapy (100mm VAS in diary)

Secondary Outcome Measures

Name	Time	Method
acute and delayed vomiting	Each patient: each day for 5 days after chemotherapy; recruitment: six weeks	vomiting that occurs within 5 days of chemotherapy (100mm VAS in diary)
interference of nausea or vomiting with everyday life	Each patient: measured at day 5 after chemotherapy; recruitment: six weeks	Functional Living Index Cancer (FLIE)
adherence to antiemetics	Each patient: each day for 5 days after chemotherapy; recruitment: six weeks	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)
antiemetic prescription	Each patient: at day of chemotherapy at discharge from dayclinic; recruitment: six weeks	antiemetic medication that is prescribed
patient-related barriers to antiemetics	Each patient: measured at day 5 after chemotherapy; recruitment: six weeks	Nausea and Vomiting Management Barriers Questionnaire (NVMBQ)
acute nausea	Each patient: at day of chemotherapy at discharge from dayclinic; recruitment: six weeks	nausea that occurs within 24 hours of chemotherapy (100mm VAS in diary)

Trial Locations

Locations (1)

ZeTuP; 🇨🇭 St. Gallen, Switzerland