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Completed

NCT Number: NCT04342780

Prevalence of Delayed Chemotherapy Associated Nausea

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

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Key information

Conditions

Chemotherapy-induced Nausea and Vomiting Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ZeTuP

Sankt Gallen, 9000, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. acute nausea

    Time frame: 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)

  2. acute and delayed vomiting

    Time frame: Each patient: each day for 5 days after chemotherapy; recruitment: six weeks

    vomiting that occurs within 5 days of chemotherapy (100mm VAS in diary)

  3. adherence to antiemetics

    Time frame: 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)

  4. antiemetic prescription

    Time frame: Each patient: at day of chemotherapy at discharge from dayclinic; recruitment: six weeks

    antiemetic medication that is prescribed

  5. interference of nausea or vomiting with everyday life

    Time frame: Each patient: measured at day 5 after chemotherapy; recruitment: six weeks

    Functional Living Index Cancer (FLIE)

  6. patient-related barriers to antiemetics

    Time frame: Each patient: measured at day 5 after chemotherapy; recruitment: six weeks

    Nausea and Vomiting Management Barriers Questionnaire (NVMBQ)

Sponsors and collaborators

Lead sponsor

Antje Koller

Other

Collaborators

  • Dr.-Hans-Altschüler-Stiftung
  • Spital Thurgau AG
  • University Medical Center Freiburg
  • ZETUP St. Gallen

Registry information

Official study title

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

Acronym: CINrate

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 13, 2020
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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