Antiemetic TherapyEMESISNCT00911222
Epidemiological EMESIS-Registry
An observational study of Antiemetic Therapy, run by iOMEDICO AG at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antiemetic Therapy
- What is being tested?
- non-interventional
- How many people
- 1,035 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2008to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Practitioners specialized in oncology, hematology and/or gynaecology
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiologic Registry for the Description of Antiemetic Strategies Under Real-life Conditions.
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.
- Conditions
- Antiemetic Therapy
- Being tested
- non-interventional
- Keywords
- antiemetic therapy, emesis, vomiting, nausea, moderately and highly emetogenic chemotherapy, cisplatin, carboplatin, oxaliplatin, anthracycline, cyclophosphamid
- Medical subject headings
- Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventionalOther
non-interventional
| Study group | Role | What they receive |
|---|---|---|
| antiemetic treatment | epidemiological registry Receives: Other: non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of anti-emetic therapies dependent on the rate "complete and major control" of nausea and emesis in moderately and highly emetogenic chemotherapy regimens.
Measured: 4 chemotherapy applications per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startOct 2008
- Primary completionMay 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Antiemetic TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,035 participants (actual)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arbeitsgemeinschaft fur Internistische Onkologie, ASORS, Arbeitskreis Klinische Studien, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Jan Schröder, Dr. med. / MD, Principal investigator, Praxis für Hämatologie und Onkologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911222
- Sponsor's protocol ID
- IOM-143
- Other IDs
- IOM-143
- Acronym
- EMESIS
- Status last verified
- Dec 2014
- First submitted
- 28 May 2009
- Last updated
- 24 Dec 2014
- Results posted
- No
Publications
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.
PubMed 16717289MASCC guidelines: Consensus Conference on Antiemetic Therapy, Perugia, march 29 - 31. 2004, update: December 2007)
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.
PubMed 8692559Laszlo 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.
PubMed 7278899Gralla 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.
PubMed 1857886Charlson 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.
PubMed 3558716
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Registry for the Description of Antiemetic Strategies Under Real-life Conditions.
- ClinicalTrials.gov ID
- NCT00911222
- Acronym / sponsor ID
- EMESIS / IOM-143
- Conditions
- Antiemetic Therapy
- Keywords
- antiemetic therapy, emesis, vomiting, nausea, moderately and highly emetogenic chemotherapy, cisplatin, carboplatin, oxaliplatin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,035 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Collaborators
- Arbeitsgemeinschaft fur Internistische Onkologie, ASORS, Arbeitskreis Klinische Studien, Merck Sharp & Dohme LLC
- Study start
- Oct 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 1 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| antiemetic treatment | – | Other: non-interventionalepidemiological registry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Practitioners specialized in oncology, hematology and/or gynaecology
Key inclusion criteria (7 listed)
- 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%)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-interventionalnon-interventional | Other | antiemetic treatment |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
- Background: PubMed 16717289American 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.
- BackgroundMASCC guidelines: Consensus Conference on Antiemetic Therapy, Perugia, march 29 - 31. 2004, update: December 2007)
- Background: PubMed 8692559Osoba 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.
- Background: PubMed 7278899Laszlo 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.
- Background: PubMed 1857886Gralla 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.
- Background: PubMed 3558716Charlson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Schröder, Dr. med. / MD principal investigator
Praxis für Hämatologie und Onkologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiemetic Therapy, run by iOMEDICO AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 4 chemotherapy applications per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00911222, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2014.