Potential drug interactions among cancer patients using oral cytostatic drugs: a prevalence study
ISRCTN | ISRCTN01739090 |
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DOI | https://doi.org/10.1186/ISRCTN01739090 |
Secondary identifying numbers | N/A |
- Submission date
- 13/12/2011
- Registration date
- 20/02/2012
- Last edited
- 29/10/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
Prof. Debyelaan 25
Dept. of Clinical Pharmacy and Toxicology
Maastricht
6229HX
Netherlands
Phone | +31 (0)43 387 1881 |
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r.w.f.vanleeuwen@erasmusmc.nl |
Study information
Study design | Multicenter cross-sectional study |
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Primary study design | Observational |
Secondary study design | Cross sectional study |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Potential drug interactions among cancer patients using oral cytostatic drugs: a multicenter cross-sectional study |
Study objectives | 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(s) | Ethics board of Isala Clinics, 24/03/2011, ref: 11.0334N |
Health condition(s) or problem(s) studied | 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 |
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 study start date | 01/01/2012 |
Completion date | 01/06/2012 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 1000 |
Key inclusion criteria | All ambulatory patients with the diagnosis solid tumour or a malignant haematological disease who are receiving oral anticancer therapy |
Key exclusion criteria | 1. The use of experimental trial agents 2. Age <18 years 3. The use of oral anticancer drugs for non-oncological diseases |
Date of first enrolment | 01/01/2012 |
Date of final enrolment | 01/06/2012 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
6229HX
Netherlands
Sponsor information
Hospital/treatment centre
Prof. Debyelaan 25
Maastricht
6229HX
Netherlands
r.van.leeuwen@mumc.nl | |
https://ror.org/02d9ce178 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |