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Effects and side effects of strong-acting opioids for the treatment of cancer-related pain: a study of the role of differences in metabolism (degradation) of the medicine and differences in genes


- candidate number15995
- NTR NumberNTR4369
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jan-2014
- Secondary IDsZonMw 11510014 EudraCT Number: 2009-013022-16
- Public TitleEffects and side effects of strong-acting opioids for the treatment of cancer-related pain: a study of the role of differences in metabolism (degradation) of the medicine and differences in genes
- Scientific TitleEffects en side effects of strong-acting opioids: a study on the role of pharmacokinetic and pharmacogenetic heterogeneity
- ACRONYM
- hypothesisVariations in pharmacogenetics and or pharmacogenetics are related to clinical outcome of treatment with strong-acting opioids for cancer-related pain
- Healt Condition(s) or Problem(s) studiedPain, Pharmacogenetics, Pharmacokinetics, Cancer-related pain
- Inclusion criteriaHospitalized patients treated with strong-acting opioids for moderate to severe cancer related nociceptive pain. Starting treatment with strong-acting opioids or needing adjustment of current treatment
- Exclusion criteriaEstimated duration of hospitalisation < 72 hours
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2010
- planned closingdate
- Target number of participants350
- InterventionsTreatment is given according to physician's choice Blood samples drawn for pharmacogenetic analysis in all patients Blood samples drawn for pharmacokinetic analysis in patients who consent only
- Primary outcome- Are variations in pharmacogenetics and/or pharmacokinetics related to insufficient pain control and/or the occurrence of intolerable side effects? - To study the role of demographic and clinical factors on outcome of treatment - To study how the factors mentioned above affect the outcome of opioid rotation
- Secondary outcome-
- TimepointsInclusion of patients until the end of 2014 Start validation phase per 1-1-2015
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, Medical Oncologist A, Oosten
- CONTACT for SCIENTIFIC QUERIESMD. C.C.D. Rijt, van der
- Sponsor/Initiator Erasmus Medical Center, Daniel den Hoed Cancer Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus University Medical Centre, M-RACE, ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsNot yet
- Brief summaryThis is a study to investigate the role of demographic and clinical factors, pharmacokinetic and pharmacogenetic variations on the outcome of treatment with strong-acting opioids for cancer related pain. Also, factors influencing the outcome of opioid rotation are studied. Based on these factors recommendations will be made which will validated in the second phase of the study
- Main changes (audit trail)24-3-2014: trial overgezet naar website: LH
- RECORD6-jan-2014 - 24-mrt-2014


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