Condition category
Signs and Symptoms
Date applied
16/07/2007
Date assigned
16/07/2007
Last edited
17/07/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr H.J. Doodeman

ORCID ID

Contact details

Medical Centre Alkmaar
Hospital Pharmacy
P.O. Box 501
Alkmaar
1800 AM
Netherlands
+31 (0)72 548 3591
h.j.doodeman@mca.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P05.0473L

Study information

Scientific title

Acronym

Study hypothesis

1. Adherence to guidelines/protocols is unsatisfactory
2. No regimen is superior in the proportion of patients with minimal or no impact of emesis on daily living as measured using the Functional Living Index-Emesis questionnaire

Ethics approval

Approval received from the local medical ethics committee (Medisch Ethische Toetsingscommissie Noord-Holland [METC Noord-Holland]) on the 12th April 2005 (ref: M05-011).

Study design

Multicentre, observational, outcomes research study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

Quality of life and chemotherapy induced nausea and vomiting

Intervention

This study uses self reported sides effects including nausea and vomiting by means of a patient diary which also includes a quality of life assessment.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. To make an inventory on the anti-emetic policy in several peripheral hospitals
2. To make an inventory on the effectiveness of these anti-emetic policies

Secondary outcome measures

1. What is the difference in anti-emetic policies used in several peripheral hospitals?
2. Do these anti-emetic policies correspond with evidence based guidelines?
3. Is aprepitant used in high emetogenic chemotherapy treatment or moderate emetogenic chemotherapy treatment?
4. What is the incidence of acute and delayed nausea and vomiting in chemotherapy treatment and does this correspond with literature?
5. Can differences in effectiveness be explained by differences in patient characteristics, chemotherapy and/or anti-emetic policy?

Overall trial start date

15/04/2005

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Chemotherapy naive patients receiving chemotherapy.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

600

Participant exclusion criteria

1. Life expectancy less than three months
2. Lack of basic proficiency in Dutch
3. Age below 18
4. Pregnancy
5. Psychological illness

Recruitment start date

15/04/2005

Recruitment end date

01/09/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Medical Centre Alkmaar
Alkmaar
1800 AM
Netherlands

Sponsor information

Organisation

Medical Centre Alkmaar (Medisch Centrum Alkmaar) (The Netherlands)

Sponsor details

Hospital Pharmacy
Alkmaar
1800 AM
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.mca.nl/webframe/modules/mod_webcontroleur/voorkant.php?id=5

Funders

Funder type

Hospital/treatment centre

Funder name

Medical Centre Alkmaar (Medisch Centrum Alkmaar) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes