gynaecological cancer
Conditions
Interventions
Group 1: Standard chemotherapy
during therapy nausea and vomiting will be recorded via patient questionnaires and daily diary.
No interventions will be performed.
Sponsors
NOGGO e.V. Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Diagnosis with primary gynaecological cancer and/or breast cancer - Planned chemotherapy for at least three cycles, adjuvant and neoadjuvant (as standard of care)
Exclusion criteria
Exclusion criteria: - Chemotherapy has already started - Tumour of a different origin - Metastases in the central nervous system - Bowel obstruction/ Ileus/ Subileus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is prediction of CINV within the first three cycles and evaluation of a risk score; after first phase of the study and data evaluation the risk score will be assessed and tested in the 2nd study phase | — |
Secondary
| Measure | Time frame |
|---|---|
| - Incidence and NCI-CTC grade of AE, - Dose reduction, - Delay of therapy, - Early termination of therapy and the reasons, - Quality of life and the development of it from baseline to 3rd and 6th cycle | — |
Countries
Germany
Outcome results
None listed