Prevalence of Delayed Chemotherapy Associated Nausea (CINrate)

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

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

Study Overview

• Status: Completed
• Conditions: Chemotherapy-induced Nausea and Vomiting

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 Type: Observational
• Enrollment (Actual): 172

Contacts and Locations

• Study Contact: Name: Antje Koller, PhD; Phone Number: 1213 004171226; Email: antje.koller@ost.ch
• Study Contact Backup: Name: Ramona Engst, MAS; Phone Number: 1554 004171226; Email: ramona.engst@ost.ch

Study Locations

• Switzerland
  • St. Gallen, Switzerland, 9000
    • ZeTuP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult oncology patients in dayclinics

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
antiemetic prescription	antiemetic medication that is prescribed	Each patient: at day of chemotherapy at discharge from dayclinic; recruitment: six weeks
interference of nausea or vomiting with everyday life	Functional Living Index Cancer (FLIE)	Each patient: measured at day 5 after chemotherapy; recruitment: six weeks
patient-related barriers to antiemetics	Nausea and Vomiting Management Barriers Questionnaire (NVMBQ)	Each patient: measured at day 5 after chemotherapy; recruitment: six weeks

Collaborators and Investigators

• Sponsor: Antje Koller
• Collaborators: University Medical Center Freiburg; ZETUP St. Gallen; Dr.-Hans-Altschüler-Stiftung; Spital Thurgau AG
• Investigators: Principal Investigator: Antje Koller, Ostschweizer Fachhochschule St. Gallen

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: oncology; prevalence; chemotherapy-induced nausea and vomiting; suportive care
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID Numbers: CINrate

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: we are planning to store anonymized data for further scientific use, however, this is depending on the vote of the ethical committee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No