breast cancer, brachytherapy, skin toxicity, spacer mammacarcinoom, brachytherapie, huidtoxiciteit, spacer
Conditions
Interventions
subcutaneous injection of 5-10ml hyaluronic acid (Barrigel of Restylane SubQ) as a spacer during PBSI
Intervention group receives PBSI treatment with spacer injection, control group receives PBSI wit
Sponsors
Franciscus Gasthuis en Vlietland
Erasmus MC- Kanker Instituut
Eligibility
Inclusion criteria
Inclusion criteria: • Female • Age 50 years or above • A confirmed histological diagnosis of invasive ductal carcinoma (IDC) or DCIS • Treated by breast conserving surgery with axillary node dissection (with a minimum of 6 nodes sampled) or sentinel lymph node biopsy • A maximum tumor size of 3 cm • Clear surgical margins at ink for IDC and ≥ 2 mm for DCIS or re-excision negative • PBSI technically feasible • Node negative (axillary lymph node dissection or sentinel node biopsy) • Informed consent signed
Exclusion criteria
Exclusion criteria: • Lymphovascular invasion • Known allergy for hyaluronic acid • Neo-adjuvant chemotherapy • Active auto immune disorder with severe vasculitis component • Uncontrolled and complicated diabetes insulin-dependent • Pregnancy • Cosmetic breast implants • Psychiatric or addictive disorder that would preclude attending follow-up • Post-operative wound infection or abscess following CDC criteria • Lobular features on histology (pure or mixed) or sarcoma histology • Extensive in situ carcinoma • Multicentric disease (in more than one quadrant or separated by 2 cm or more) • Paget’s disease of the nipple • Metastases or active other cancer • Patients presenting with a post-surgical fluid cavity ≥ 2.5 cm in diameter in the direction of implanted needled as determined on the planning US, resistant to 4 weeks of hot compresses application • Clear delineation of the target volume on CT is not possible (WBR recommended) • Having a volume to be implanted over 150cc • Having a target volume too close to skin such that the 90% isodose overlaps the skin surface • Inability to read Dutch
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of teleangiectasia, following Bentzen's four point scale (LENTSOMA), after 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| local recurrence, disease free and overall survival, induration wound infection cosmetic results and health related quality of life costeffectiveness. Validation of a Dutch translation of the BCTOS questionnaire | — |
Contacts
Public ContactGerson M. Struik
Kleiweg 500
Outcome results
None listed