Potential drug interactions among cancer patients using oral cytostatic drugs: a prevalence study

ISRCTN	ISRCTN01739090
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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Roelof van Leeuwen
Scientific

Prof. Debyelaan 25
Dept. of Clinical Pharmacy and Toxicology
Maastricht
6229HX
Netherlands

Phone	+31 (0)43 387 1881
Email	r.w.f.vanleeuwen@erasmusmc.nl

Study information

Study design	Multicenter cross-sectional study
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
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

Maastricht University Medical Centre

Maastricht
6229HX
Netherlands

Sponsor information

Maastricht University Medical Centre (Netherlands)
Hospital/treatment centre

Prof. Debyelaan 25
Maastricht
6229HX
Netherlands

Email	r.van.leeuwen@mumc.nl
"ROR"	https://ror.org/02d9ce178

Funders

Funder type

Hospital/treatment centre

Maastricht University Medical Centre (Netherlands)

No information available

Results and Publications

Intention to publish date
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