NCT00911222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,035

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

December 24, 2014

Status Verified

December 1, 2014

Enrollment Period

7 months

First QC Date

May 28, 2009

Last Update Submit

December 23, 2014

Conditions

Antiemetic Therapy

Keywords

antiemetic therapyemesisvomitingnauseamoderately and highly emetogenic chemotherapycisplatincarboplatinoxaliplatinanthracyclinecyclophosphamid

Outcome Measures

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.

    4 chemotherapy applications per patient

Study Arms (1)

antiemetic treatment

epidemiological registry

Other: non-interventional

Interventions

non-interventionalOTHER

non-interventional

antiemetic treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Practitioners specialized in oncology, hematology and/or gynaecology

You may qualify if:

  • Moderately or highly emetogenic chemotherapy consisting of platin-derivates (cisplatin, carboplatin and oxaliplatin), anthracyclines and/or cyclophosphamid.
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

iOMEDICO AG

Freiburg im Breisgau, Baden-Wurttemberg, 79108, Germany

Location

Related Publications (6)

  • 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.

    PMID: 16717289BACKGROUND

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

    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.

    PMID: 8692559BACKGROUND

  • 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.

    PMID: 7278899BACKGROUND

  • 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.

    PMID: 1857886BACKGROUND

  • 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.

    PMID: 3558716BACKGROUND

MeSH Terms

Conditions

VomitingNausea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jan Schröder, Dr. med. / MD

    Praxis für Hämatologie und Onkologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2009

First Posted

June 1, 2009

Study Start

October 1, 2008

Primary Completion

May 1, 2009

Study Completion

August 1, 2009

Last Updated

December 24, 2014

Record last verified: 2014-12

Locations

DE(1)