A study on the use of a subcutaneous injection to reduce skin side effects of breast brachytherapy with palladium seeds.
- Conditions
- breast cancer, brachytherapy, skin toxicity, spacer<br />mammacarcinoom, brachytherapie, huidtoxiciteit, spacer
- Registration Number
- NL-OMON23164
- Lead Sponsor
- Franciscus Gasthuis en Vlietland<br>Erasmus MC- Kanker Instituut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 231
Inclusion Criteria
•Female
•Age 50 years or above
Exclusion Criteria
•Lymphovascular invasion
•Known allergy for hyaluronic acid
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of teleangiectasia, following Bentzen's four point scale (LENTSOMA), after 2 years.
- Secondary Outcome Measures
Name Time Method local recurrence, disease free and overall survival,<br /><br>induration<br /><br>wound infection<br /><br>cosmetic results and health related quality of life<br /><br>costeffectiveness.<br /><br>Validation of a Dutch translation of the BCTOS questionnaire