Clinical trial NCT00911222: Epidemiological EMESIS-Registry
Official title: Epidemiologic Registry for the Description of Antiemetic Strategies Under Real-life Conditions.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antiemetic Therapy
Keywords: antiemetic therapy
emesis
vomiting
nausea
moderately and highly emetogenic chemotherapy
cisplatin
carboplatin
oxaliplatin
anthracycline
cyclophosphamid
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
Collaborators: name: Arbeitsgemeinschaft fur Internistische Onkologie
name: ASORS
name: Arbeitskreis Klinische Studien
name: Merck Sharp & Dohme LLC
First posted: 2009-06-01
Enrollment: 1035
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Practitioners specialized in oncology, hematology and/or gynaecology

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.


Eligibility 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

Primary outcomes:
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.
timeFrame: 4 chemotherapy applications per patient
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: iOMEDICO AG
state: Baden-Württemberg
Study officials:
affiliation: Praxis für Hämatologie und Onkologie
name: Jan Schröder, Dr. med. / MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: American Society of Clinical Oncology; Kris MG, Hesketh PJ, Somerfield MR, Feyer P, Clark-Snow R, Koeller JM, Morrow GR, Chinnery LW, Chesney MJ, Gralla RJ, Grunberg SM. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol. 2006 Jun 20;24(18):2932-47. doi: 10.1200/JCO.2006.06.9591. Epub 2006 May 22.
citation: MASCC guidelines: Consensus Conference on Antiemetic Therapy, Perugia, march 29 - 31. 2004, update: December 2007)
citation: Osoba D, Zee B, Warr D, Kaizer L, Latreille J, Pater J. Quality of life studies in chemotherapy-induced emesis. Oncology. 1996 Jun;53 Suppl 1:92-5. doi: 10.1159/000227647.
citation: Laszlo J, Lucas VS Jr. Emesis as a critical problem in chemotherapy. N Engl J Med. 1981 Oct 15;305(16):948-9. doi: 10.1056/NEJM198110153051609. No abstract available.
citation: Gralla RJ. Controlling emesis in patients receiving cancer chemotherapy. Recent Results Cancer Res. 1991;121:68-85. doi: 10.1007/978-3-642-84138-5_9. No abstract available.
citation: Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.