Markers for Acute Chemotherapy-Induced Cardiovascular Changes

ISRCTN	ISRCTN54551960
DOI	https://doi.org/10.1186/ISRCTN54551960
Protocol serial number	N/A
Sponsor	University Medical Center Groningen (UMCG), Department of Internal Medicine: Division of Medical Oncology (The Netherlands)
Funder	University Medical Center Groningen (UMCG)

Submission date: 19/07/2006
Registration date: 19/07/2006
Last edited: 19/07/2006

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

Not provided at time of registration

Contact information

Dr E.C. Haas de
Scientific

Medische Oncologie
University Medical Center Groningen
Hanzeplein 1
Groningen
9713 GZ
Netherlands

Phone	+31 (0)50 3612821
Email	e.c.de.haas@int.umcg.nl

Study information

Primary study design	Observational
Study design	An observational study
Secondary study design	Cohort study
Scientific title
Study acronym	MACC1
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Cisplatin
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	50 Years
Sex	Male
Target sample size at registration	50
Key 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
Key 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)
Date of first enrolment	16/05/2006
Date of final enrolment	01/05/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Medische Oncologie

Groningen
9713 GZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan