Condition category
Cancer
Date applied
13/12/2011
Date assigned
20/02/2012
Last edited
29/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 ƒ×-glutamyltransferase (ƒ×-GT)] are extracted from the laboratory database of the hospital.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes