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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014