Primary Objective:To identify suitable markers and their time course in order to better understand BEP chemotherapy induced oxidative stress in a minimally invasive manner.Secondary Objective:To measure the effect of chemotherapy on the elasticity…
ID
Source
Brief title
Condition
- Iron and trace metal metabolism disorders
- Reproductive neoplasms female malignant and unspecified
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1.Concentrations of free iron, i.e. non protein bound iron (NPBI), ferritin,
transferritin and latent iron binding capacity (LIBC)
Secondary outcome
2.Vascular parameters
3.Lipid profile and gonadal and gonadotrophin hormone concentrations (these are
routinely assessed)
4.hepatic triglyceride content
5.Assessment of immune responses pre- and post-chemotherapy against testis
antigens
Background summary
Bleomycin, etoposide and cispatin (BEP) chemotherapy is highly effective in
germ cell cancer. Nowadays 90% of the patients treated for testicular cancer
have a normal life expectancy. However, BEP chemotherapy has considerable side
effects and long term complications such as reduced fertility, renal
insufficiency, pulmonary fibrosis, cardiovascular complications, neurotoxicity,
ototoxicity and osteoporosis.
In order to better understand the phenomena underlying the (long-term) effects
of BEP chemotherapy a study is proposed to investigate the biochemical (short
term) toxic effects of these cytostatics.
Study objective
Primary Objective:
To identify suitable markers and their time course in order to better
understand BEP chemotherapy induced oxidative stress in a minimally invasive
manner.
Secondary Objective:
To measure the effect of chemotherapy on the elasticity of arterial walls which
may be mediated by chemotherapy-induced oxidative stress.
To investigate the changes in hepatic triglyceride content using Proton
Magnetic Resonance Spectroscopy (1H-MRS).
To investigate the changes in immune response against testis antigens in
patients undergoing curative chemotherapy.
Study design
The schedule of assessments for the entire study is divided into 3 parts that
are listed below.
a. Eligibility assessment (within 30 days before scheduled start of cytostatic
therapy)
- Informed consent
- medical history
- blood sampling
- urine collection
- vascular assesment
- Measurements of HTGC
b. Study days (12 hrs study period) simultaneous with the first two courses of
cisplatin infusion and the first course of bleomycin infusion (detailed scheme
is provided in paragraph 8.3)
- blood sampling
- vascular assesment
- Measurements of HTGC
c. Follow-up
In the first year post chemotherapy, each patient will visit the outpatient
clinic of LUMC for routine follow-up once per month. At these follow up visits,
at 3, 6 and 9 months after start of the chemotherapy treatment period, the
following assessments will be done:
- medical history
- blood sampling
- urine collection
- vascular assesment
Study burden and risks
No risk neither benefit is associated with participation.
Albinusdreef 2
2333 ZA Leiden
Nederland
Albinusdreef 2
2333 ZA Leiden
Nederland
Listed location countries
Age
Inclusion criteria
adults willing and able to give written informed consent
in case of patients: those who are scheduled to undergo chemotherapy for testicular cancer.
Exclusion criteria
no
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL17574.058.07 |