Contact information
Type
Scientific
Primary contact
Dr E.C. Haas de
ORCID ID
Contact details
Medische Oncologie
University Medical Center Groningen
Hanzeplein 1
Groningen
9713 GZ
Netherlands
+31 (0)50 3612821
e.c.de.haas@int.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
MACC1
Study hypothesis
1. The number of circulating endothelial (progenitor) cells may be reduced during chemotherapy and correlate to the development of cardiovascular disease
2. Oxidative stress due to chemotherapy may lead to an increased accumulation of advanced glycation end products (AGEs) in blood vessels, contributing to endothelial damage
Ethics approval
Not provided at time of registration
Study design
An observational study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Testicular cancer
Intervention
The number of circulating endothelial cells, endothelial marker proteins and accumulation of AGEs (estimated by measuring skin autofluorescence with an AGE-reader) will be determined before, during and after chemotherapy.
Cardiovascular status (intima-media thickness of the carotid artery, baroreflex sensitivity and 24-hour ambulatory blood pressure measurement) will be evaluated before start of chemotherapy, within four weeks after completion of chemotherapy and one year after start of chemotherapy.
Intervention type
Drug
Phase
Not Specified
Drug names
Cisplatin
Primary outcome measures
The early effects of cisplatin-based chemotherapy on the number of circulating endothelial (progenitor) cells and the accumulation of AGEs, and their correlation with cardiovascular damage
Secondary outcome measures
1. Evaluation of which treatment and patient-related factors (for example chemotherapy dose and presence of cardiovascular risk factors) predispose patients to cardiovascular damage during and after cisplatin-based chemotherapy
2. Determination of circulating apoptosis markers during and after cisplatin-based chemotherapy and their relation to tumor response and cardiovascular damage
Overall trial start date
16/05/2006
Overall trial end date
01/05/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with disseminated testicular cancer who will be treated with cisplatin based chemotherapy
2. Age 18-50 years at start of treatment
3. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
50
Participant exclusion criteria
1. Medical history of cardiovascular disease
2. Known renal disease or estimated glomerular filtration rate (GFR) <60 ml/min (using Cockcroft-Gault formula)
Recruitment start date
16/05/2006
Recruitment end date
01/05/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Medische Oncologie
Groningen
9713 GZ
Netherlands
Funders
Funder type
University/education
Funder name
University Medical Center Groningen (UMCG)
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