Development of a Risk Prediciton Model for Chemotherapy-induced Nausea and Vomiting
Recruiting
- Conditions
- gynaecological cancer
- Registration Number
- DRKS00015151
- Lead Sponsor
- OGGO e.V. Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 519
Inclusion Criteria
Diagnosis with primary gynaecological cancer
- Planned chemotherapy for at least three cycles, adjuvant and neoadjuvant (as standard of care)
Exclusion Criteria
- Breast cancer
- Chemotherapy has already started
- Tumour of a different origin
- Metastases in the central nervous system
- Bowel obstruction/ Ileus/ Subileus
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method - Incidence and NCI-CTC grade of AE,<br>- Dose reduction,<br>- Delay of therapy,<br>- Early termination of therapy and the reasons,<br>- Quality of life and the development of it from baseline to 3rd and 6th cycle