Epidemiological EMESIS-Registry

Completed

• Conditions: Antiemetic Therapy
• Interventions: Other: non-interventional

• Registration Number: NCT00911222
• Lead Sponsor: iOMEDICO AG

Brief Summary

The purpose of this registry is to record information on reality of anti-emetic therapies of cancer-patients in Germany. The outcome of this study is the efficacy of anti-emetic therapies dependent on the rate "complete and major control" of nausea and emesis in moderately and highly emetogenic chemotherapies, consisting of platin-derivates (cisplatin, carboplatin and oxaliplatin), anthracyclines and/or cyclophosphamid.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2009-05
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-29
• Study First Posted: 2009-06-01
• Study Completion: 2009-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-23
• Last Update Posted: 2014-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1035

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
antiemetic treatment	non-interventional	epidemiological registry

Primary Outcome Measures

Name	Time	Method
Efficacy of anti-emetic therapies dependent on the rate "complete and major control" of nausea and emesis in moderately and highly emetogenic chemotherapy regimens.	4 chemotherapy applications per patient

Trial Locations

Locations (1)

iOMEDICO AG; 🇩🇪 Freiburg, Baden-Württemberg, Germany