|- candidate number||2635|
|- NTR Number||NTR1001|
|- Date ISRCTN created||16-jul-2007|
|- date ISRCTN requested||9-jul-2007|
|- Date Registered NTR||19-jun-2007|
|- Secondary IDs||P05.0473L |
|- Public Title||A multicentre outcome research in daily clinical practice concerning the prevention of acute and delayed nausea and vomiting after chemotherapy: an outcome research.
|- Scientific Title||A multicentre outcome research in daily clinical practice concerning the prevention of acute and delayed nausea and vomiting after chemotherapy: an outcome research.
|- 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.
|- Healt Condition(s) or Problem(s) studied||Nausea , Quality of life, Chemotherapy, Adherence to guidelines, Vomiting|
|- Inclusion criteria||1. Chemotherapy naive patients receiving chemotherapy.|
|- Exclusion criteria||1. Life expectancy less than three months;|
2. Lack of basic proficiency in Dutch;
3. Age below 18;
5. Psychological illness.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||15-apr-2005|
|- planned closingdate||1-sep-2007|
|- Target number of participants||600|
|- Interventions||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.
|- Primary outcome||1. To make an inventory on the antiemetic policy in several peripheral hospitals;|
2. To make an inventory on the effectiveness of these antiemetic policies.
|- Secondary outcome||1. What is the difference in antiemetic policies used in several peripheral hospitals?|
2. Do these antiemetic 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 antiemetic policy?
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| H.J. Doodeman|
|- CONTACT for SCIENTIFIC QUERIES|| P.H.A.M. Kloeg|
|- Sponsor/Initiator ||Medical Centre Alkmaar, Hospital Pharmacy |
(Source(s) of Monetary or Material Support)
|Medical Centre Alkmaar, Hospital Pharmacy |
|- Brief summary||Nausea and vomiting are still two of the most serious side effects in chemotherapy treatment, even after the introduction of 5HT3 antagonists. The effectiveness of antiemetics used in the prevention of nausea and vomiting is not sufficient according to literature. Especially the prevention of delayed nausea and vomiting is difficult.|
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.
This outcomes research provides insight into the effectiveness of antiemetic policies in daily practice, in several peripheral hospitals.
|- Main changes (audit trail)|
|- RECORD||19-jun-2007 - 9-dec-2009|