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Drug interactions and duplicate prescriptions among ambulatory cancer patients.


- candidate number7829
- NTR NumberNTR2238
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-mrt-2010
- Secondary IDs2009/137 METC VUmc
- Public TitleDrug interactions and duplicate prescriptions among ambulatory cancer patients.
- Scientific TitlePotential drug interactions and duplicate prescriptions among ambulatory cancer patients; a prevalence study using new screening methods.
- ACRONYM
- hypothesisThe pharmacotherapeutic treatment of patients with cancer is generally associated with multiple side-effects. The cause of the side-effects is usually due to the toxicity of the drugs themselves. In addition, drug interactions can intensify side-effects. In general, interactions are the cause of approximately 20-30% of all drug side-effects, of which 70% needs clinical attention and 1-2% is even life-threatening [1]. Cancer patients are particularly susceptible to drug interactions [2]. In addition to chemotherapy, cancer patients often use co-medication to treat cancer related pain and venous thrombosis or to reduce the side-effects of the anti-cancer drugs. Interactions with drugs used to treat comorbidities can also occur.
- Healt Condition(s) or Problem(s) studiedDrug interactions, Ambulatory cancer patients, OTC drugs
- Inclusion criteriaAll patients with solid and hematologic malignancy currently using systemic anti-cancer drugs are asked to participate in the study.
- Exclusion criteria1. Unable to fill out questionnaires;
2. The use of trial medication;
3. A lack of command of the Dutch language;
4. Younger than 18 years old.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-nov-2009
- planned closingdate1-mei-2010
- Target number of participants300
- InterventionsThe patients are asked to complete a short questionnaire followed by an interview. The questionnaire contains questions about the demographic characteristics (available online as appendix). A list of the medication used to treat comorbidities for a period of six months prior to the study is requested from the patientsí community pharmacy and this is discussed in the interview with the patient. During this interview the patient is also asked about the comorbidity and the use of OTC drugs. Data about the use of anti-cancer drugs, diagnose, aim of treatment (palliative/adjuvant), treatment start date and cancer-related co-medication is gathered by medical chart review and, if necessary, in an interview with the prescribing doctor. The most recent renal function (creatinine) value and liver function parameters (ASAT, ALAT and „-GT) is obtained from the laboratory database of the hospital.
- Primary outcomeThe aim of the present study is to gain more insight into the prevalence of interactions and duplicate prescriptions among cancer patients being treated in the outpatient day care departments for oncology and hemato-oncology. This will be the first study into the prevalence of drug interactions with OTC-drugs in cancer patients.
- Secondary outcomePossible risk factors for the occurrence of these drug-related problems will also be studied.
- TimepointsBefore or during administration of cytotoxic drugs.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. J.G. Hugtenburg
- CONTACT for SCIENTIFIC QUERIESDr. J.G. Hugtenburg
- Sponsor/Initiator VU University Medical Center, Zaans Medisch Centrum
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center, Zaans Medisch Centrum
- PublicationsN/A
- Brief summaryThe pharmacotherapeutic treatment of patients with cancer is generally associated with multiple side-effects. Drug interactions and duplicate prescriptions between anti-cancer drugs or interactions with medication to treat comorbidity can reinforce or intensify side-effects. The aim of the present study is to gain more insight into the prevalence of drug interactions and duplicate prescriptions among patients being treated in the outpatient day care departments for oncology and hematological illnesses. This will be the first study into the prevalence of drug interactions with OTC-drugs in cancer patients.
- Main changes (audit trail)
- RECORD9-mrt-2010 - 17-mrt-2010


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