To determine the effects of biphosphonates on radiation induced microvascular damage in the skin of breast cancer patients by comparing skin biopsies taken prior to and 4 months after treatment with a biphosphonate.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Skin vascular abnormalities
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the effects of biphosphonates on radiation induced microvascular
damage by comparison of biopsy samples of skin prior to and 4 months after
treatment with a biphosphonate.
Secondary outcome
To determine the effects of biphosphonates on radiation induced
micro-lymphovascular damage by comparison of biopsy samples of skin prior to
and after treatment with a biphosphonate.
Background summary
About half of all cancer patients who have survivied up to 20 years following
diagnosis receive radiotherapy sometimes as being one of the main components of
multimodality cancer treatment with also chemotherapy and surgery. Vascular
injury is the major cause of late radiation morbidity developing slowly and
progressively over many years and currently there is no preventative treatment.
Our hypothesis is that biphosphonate inhibit the release of bone marrow derived
mononuclear cells, and that this will have a beneficial effect on the
development of pathogenic microvasculature.
Study objective
To determine the effects of biphosphonates on radiation induced microvascular
damage in the skin of breast cancer patients by comparing skin biopsies taken
prior to and 4 months after treatment with a biphosphonate.
Study design
The study is as follows:Three different groups of patients with breast cancer
can be entered in this trial. In the past all groups underwent radiotherapy
for breast cancer and now will be treated with biphosphonate. Two times two
skin biopsies will be taken, before and after four months of treatment with a
biphosphonate. This is to compare whether biphosphonates have an effect on
inhibition of vascular damage in the irradiated skin.
Study burden and risks
Two biopsies will be taken during the regular hospital visit. It will take 10
minutes extra time. The skin round the biopsy area will be anaesthetized and a
4 mm diameter, 1 mm deep punch biopsy will be taken. A bleeding is possible but
very rare and will be solved by using a plaster.
Plesmanlaan 121
1066CX AMSTERDAM
NL
Plesmanlaan 121
1066CX AMSTERDAM
NL
Listed location countries
Age
Inclusion criteria
radiotherapie on breast > 6 months ago
will receice biphosphonate
age ><=18 years
Exclusion criteria
breast radiotherapy < 6 months ago
use of anti-coagulants
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 | NL35067.031.10 |