Plain English Summary
Background and study aims
A drug-drug interaction (DDI) is when a drug affects the activity of another drug when both are given together. Although some DDIs can be beneficial, most DDIs cause adverse reactions. Patients with cancer are particularly at risk for DDIs because they receive a large number of different drugs. Most cancer patients are also aged over 65 and so are likely to have other illnesses for which they also receive drug treatment. Over the past years there has been an increase in the number of oral anticancer drugs. The greater convenience and flexibility of oral treatment offers cancer patients a better quality of life, but patients on oral anticancer drugs are at considerable risk for DDIs. The aim of this study is to investigate the prevalence of DDIs among cancer patients on oral anticancer treatment.
Who can participate?
Patients aged over 18 who are receiving oral anticancer treatment.
What does the study involve?
We search the medication prescription system of the outpatients hospital pharmacy for the use of oral anticancer drugs within the previous 12 months. We obtain data on the type of oral anticancer drugs, supportive care and other drugs prescribed over the past 12 months, and collect information concerning the type of cancer, any other illnesses, and kidney and liver test results.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Maastricht University Medical Centre (Maastricht), Radboud University Medical Centre (Nijmegen) and Deventer Hospital (Deventer).
When is the study starting and how long is it expected to run for?
January to June 2012.
Who is funding the study?
Maastricht University Medical Centre (Netherlands).
Who is the main contact?
Dr Roelof van Leeuwen
r.w.f.vanleeuwen@erasmusmc.nl
Trial website
Contact information
Type
Scientific
Primary contact
Dr Roelof van Leeuwen
ORCID ID
Contact details
Prof. Debyelaan 25
Dept. of Clinical Pharmacy and Toxicology
Maastricht
6229HX
Netherlands
+31 (0)43 387 1881
r.w.f.vanleeuwen@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Potential drug interactions among cancer patients using oral cytostatic drugs: a multicenter cross-sectional study
Acronym
Study hypothesis
The aim of this study is to investigate the prevalence of DDIs (Drug-Drug Interactions) among ambulatory cancer patients on oral anticancer treatment. The secondary objective is to gain more insight into possible determinants for the occurrence of these DDIs.
Ethics approval
Ethics board of Isala Clinics, 24/03/2011, ref: 11.0334N
Study design
Multicenter cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cancer
Intervention
To identify the patients a search is conducted in the computer based medication prescription system of the outpatients hospital pharmacy for delivery of oral anticancer drugs in the previous 12 months. Anticancer drugs are defined as oncolytic drugs, immunomodulators and antihormonal agents. To obtain data on type of oral anticancer drugs, supportive care and comedication an overview of drugs prescribed over the past 12 months is obtained from the outpatient hospital pharmacy.
Drugs used on a continuous base and incidental use (e.g. dexamethasone during chemotherapy) are included in this study. Information concerning type of cancer and comorbidities are collected by medical chart review. Renal function [creatinine] and liver function tests [aspartate aminotransferase (AST), alanine aminotransferase (ALT) and ×-glutamyltransferase (×-GT)] are extracted from the laboratory database of the hospital.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
To investigate the prevalence of DDIs among ambulatory cancer patients on oral anticancer treatment
Secondary outcome measures
To gain more insight into possible determinants for the occurrence of these DDIs
Overall trial start date
01/01/2012
Overall trial end date
01/06/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All ambulatory patients with the diagnosis solid tumour or a malignant haematological disease who are receiving oral anticancer therapy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1000
Participant exclusion criteria
1. The use of experimental trial agents
2. Age <18 years
3. The use of oral anticancer drugs for non-oncological diseases
Recruitment start date
01/01/2012
Recruitment end date
01/06/2012
Locations
Countries of recruitment
Netherlands
Trial participating centre
Maastricht University Medical Centre
Maastricht
6229HX
Netherlands
Sponsor information
Organisation
Maastricht University Medical Centre (Netherlands)
Sponsor details
Prof. Debyelaan 25
Maastricht
6229HX
Netherlands
-
r.van.leeuwen@mumc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Maastricht University Medical Centre (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
Basic results (scientific)
Publication list