Chemotherapy-induced Nausea and VomitingCINrateNCT04342780
Prevalence of Delayed Chemotherapy Associated Nausea
An observational study of Chemotherapy-induced Nausea and Vomiting, run by Antje Koller at 1 site in Switzerland.
Trial summary
This study evaluates the prevalence of delayed chemotherapy induced nausea in adult oncology patients in real clinical practice of day clinics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- How many people
- 172 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Jun 2020to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult oncology patients in dayclinics
Who may be able to join
- first day of chemotherapy of a new cycle (any cycle)
- speak and write German
- sign the consent forms
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- prevalence, chemotherapy-induced nausea and vomiting, oncology, suportive care
- Medical subject headings
- Vomiting, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
delayed Nausea
nausea that occurs 24 hours to 5 days after chemotherapy (100mm VAS in diary)
Measured: Each patient: each days for 5 days after chemotherapy; recruitment: six weeks
Secondary outcomes (6)
acute nausea
nausea that occurs within 24 hours of chemotherapy (100mm VAS in diary)
Measured: 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)
Measured: 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)
Measured: Each patient: each day for 5 days after chemotherapy; recruitment: six weeks
antiemetic prescription
antiemetic medication that is prescribed
Measured: 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)
Measured: Each patient: measured at day 5 after chemotherapy; recruitment: six weeks
patient-related barriers to antiemetics
Nausea and Vomiting Management Barriers Questionnaire (NVMBQ)
Measured: Each patient: measured at day 5 after chemotherapy; recruitment: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start29 Jun 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antje Koller
- Sponsor type
- University, hospital or other
- Collaborators
- ZETUP St. Gallen, Dr.-Hans-Altschüler-Stiftung, University Medical Center Freiburg, Spital Thurgau AG
- Responsible party
- Sponsor-investigator, Antje Koller, St.Gallen University of Applied Sciences
- Investigators
- Antje Koller, Principal investigator, Ostschweizer Fachhochschule St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342780
- Sponsor's protocol ID
- CINrate
- Acronym
- CINrate
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 2020
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: we are planning to store anonymized data for further scientific use, however, this is depending on the vote of the ethical committee
Publications
Engst R, Glaus A, Moessner U, Ott S, Koller A. Delayed Chemotherapy-Induced Nausea - A Nurse-Led International Observational Study in Routine Oncology Practice (CINrate). SAGE Open Nurs. 2025 Dec 2;11:23779608251398116. doi: 10.1177/23779608251398116. eCollection 2025 Jan-Dec.
PubMed 41356791
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Chemotherapy-induced Nausea: A Multi-center Prevalence Survey in Adult Oncology Patients in Clinical Practice
- ClinicalTrials.gov ID
- NCT04342780
- Acronym / sponsor ID
- CINrate / CINrate
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- prevalence, chemotherapy-induced nausea and vomiting, oncology, suportive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Antje KollerUniversity, hospital or other
- Collaborators
- ZETUP St. Gallen, Dr.-Hans-Altschüler-Stiftung, University Medical Center Freiburg, Spital Thurgau AG
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult oncology patients in dayclinics
Key inclusion criteria (3 listed)
- first day of chemotherapy of a new cycle (any cycle)
- speak and write German
- sign the consent forms
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
delayed Nausea
Time frame: 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)
6 secondary outcomes
acute nausea
Time frame: Each patient: at day of chemotherapy at discharge from dayclinic; recruitment: six weeks
acute and delayed vomiting
Time frame: Each patient: each day for 5 days after chemotherapy; recruitment: six weeks
adherence to antiemetics
Time frame: Each patient: each day for 5 days after chemotherapy; recruitment: six weeks
antiemetic prescription
Time frame: Each patient: at day of chemotherapy at discharge from dayclinic; recruitment: six weeks
interference of nausea or vomiting with everyday life
Time frame: Each patient: measured at day 5 after chemotherapy; recruitment: six weeks
patient-related barriers to antiemetics
Time frame: Each patient: measured at day 5 after chemotherapy; recruitment: six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Derived from this study: PubMed 41356791Engst R, Glaus A, Moessner U, Ott S, Koller A. Delayed Chemotherapy-Induced Nausea - A Nurse-Led International Observational Study in Routine Oncology Practice (CINrate). SAGE Open Nurs. 2025 Dec 2;11:23779608251398116. doi: 10.1177/23779608251398116. eCollection 2025 Jan-Dec.
- Individual participant dataSharing planned: Undecided. we are planning to store anonymized data for further scientific use, however, this is depending on the vote of the ethical committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antje Koller principal investigator
Ostschweizer Fachhochschule St. Gallen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Nausea and Vomiting, run by Antje Koller at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delayed Nausea (time frame: Each patient: each days for 5 days after chemotherapy; recruitment: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04342780, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.