Epidemiologic Registry for the Description of Antiemetic Strategies Under Real-life Conditions.
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Antiemetic Therapy
Both
Antiemetic Therapy
Trial Information
Epidemiologic Registry for the Description of Antiemetic Strategies Under Real-life Conditions.
Inclusion Criteria:
- Moderately or highly emetogenic chemotherapy consisting of platin-derivates
(cisplatin, carboplatin and oxaliplatin), anthracyclines and/or cyclophosphamid.
- start with the 1st cycle of the regimen (chemo naive patients). Inclusion of
pretreated patients is also possible, if the last treatment cycle of a previous
chemotherapy was given >= 24 months ago.
- Compliance with registry procedures
- Age >= 18 years
- WHO Performance Status of 0 or 1 (Karnofsky-Index >= 70%)
- Life expectancy of at least 12 weeks
- Signed and dated informed consent before the start of the registry
Exclusion Criteria:
- Mentally incapable or incompliant patients
- Last chemotherapy <= 24 months (if pretreated)
- Known hypersensitivity to antiemetic medication
- unability of the patient to be treated with oral medication
- pregnancy or lactation period
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Efficacy of anti-emetic therapies dependent on the rate "complete and major control" of nausea and emesis in moderately and highly emetogenic chemotherapy regimens.
Outcome Time Frame:
4 chemotherapy applications per patient
Safety Issue:
No
Principal Investigator
Jan Schröder, Dr. med. / MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Praxis für Hämatologie und Onkologie
Authority:
Germany: Ethics Commission
Study ID:
IOM-143
NCT ID:
NCT00911222
Start Date:
October 2008
Completion Date:
August 2009
Related Keywords:
- Antiemetic Therapy
- antiemetic therapy
- emesis
- vomiting
- nausea
- moderately and highly emetogenic chemotherapy
- cisplatin
- carboplatin
- oxaliplatin
- anthracycline
- cyclophosphamid
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