Epidemiological EMESIS-Registry

NCT ID: NCT00911222

Last Updated: 2014-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1035 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Antiemetic Therapy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

antiemetic therapy emesis vomiting nausea moderately and highly emetogenic chemotherapy cisplatin carboplatin oxaliplatin anthracycline cyclophosphamid

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

antiemetic treatment

epidemiological registry

non-interventional

Intervention Type OTHER

non-interventional

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

non-interventional

non-interventional

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Arbeitsgemeinschaft fur Internistische Onkologie

OTHER

Sponsor Role collaborator

ASORS

UNKNOWN

Sponsor Role collaborator

Arbeitskreis Klinische Studien

OTHER

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

iOMEDICO AG

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jan Schröder, Dr. med. / MD

Role: PRINCIPAL_INVESTIGATOR

Praxis für Hämatologie und Onkologie

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

iOMEDICO AG

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 16717289 (View on PubMed)

MASCC guidelines: Consensus Conference on Antiemetic Therapy, Perugia, march 29 - 31. 2004, update: December 2007)

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 8692559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7278899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1857886 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3558716 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IOM-143

Identifier Type: -

Identifier Source: secondary_id

IOM-143

Identifier Type: -

Identifier Source: org_study_id