Epidemiological EMESIS-Registry

This study has been completed.
Sponsor:
Collaborators:
Arbeitsgemeinschaft internistische Onkologie
ASORS
Arbeitskreis Klinische Studien
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
iOMEDICO AG
ClinicalTrials.gov Identifier:
NCT00911222
First received: May 28, 2009
Last updated: October 8, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Antiemetic Therapy
Other: non-interventional

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiologic Registry for the Description of Antiemetic Strategies Under Real-life Conditions.

Resource links provided by NLM:


Further study details as provided by iOMEDICO AG:

Primary Outcome Measures:
  • Efficacy of anti-emetic therapies dependent on the rate "complete and major control" of nausea and emesis in moderately and highly emetogenic chemotherapy regimens. [ Time Frame: 4 chemotherapy applications per patient ] [ Designated as safety issue: No ]

Enrollment: 1035
Study Start Date: October 2008
Study Completion Date: August 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
antiemetic treatment
epidemiological registry
Other: non-interventional
non-interventional

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Practitioners specialized in oncology, hematology and/or gynaecology

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00911222

Locations
Germany
iOMEDICO AG
Freiburg, Baden-Württemberg, Germany, 79108
Sponsors and Collaborators
iOMEDICO AG
Arbeitsgemeinschaft internistische Onkologie
ASORS
Arbeitskreis Klinische Studien
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Jan Schröder, Dr. med. / MD Praxis für Hämatologie und Onkologie
  More Information

Publications:
Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT00911222     History of Changes
Other Study ID Numbers: IOM-143, IOM-143
Study First Received: May 28, 2009
Last Updated: October 8, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by iOMEDICO AG:
antiemetic therapy
emesis
vomiting
nausea
moderately and highly emetogenic chemotherapy
cisplatin
carboplatin
oxaliplatin
anthracycline
cyclophosphamid

Additional relevant MeSH terms:
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014