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Completed

NCT Number: NCT00911222

Epidemiological EMESIS-Registry

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.

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Key information

Conditions

Antiemetic Therapy Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

iOMEDICO AG

Freiburg im Breisgau, Baden-Wurttemberg, 79108, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional

Other

non-interventional

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Collaborators

  • ASORS
  • Arbeitsgemeinschaft fur Internistische Onkologie
  • Arbeitskreis Klinische Studien
  • Merck Sharp & Dohme LLC

Registry information

Official study title

Epidemiologic Registry for the Description of Antiemetic Strategies Under Real-life Conditions.

Acronym: EMESIS

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 1, 2009
Registry last updated
Dec 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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