A randomized controlled trial testing hyaluronic acid spacer injection for skin toxicity reduction of Permanent Breast Seed Implant (PBSI)

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 231

Inclusion Criteria

* Female
* Age * 50 years
* A confirmed histological diagnosis of
* invasive ductal carcinoma (IDC), Papillary/tubular/cribriform/medullar carcinoma,DCIS or combination of these tumortypes
* 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), nodes with isolated tumor cells are eligible
* Informed consent signed

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
* Pacemaker/ICD
* 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
* Triple negative tumors
* Extensive in situ carcinoma
* Multicentric disease (in more than one quadrant or separated by 2 cm or more)Bilateral breast cancer
* Recurrent breast cancer
* Paget*s disease of the nipple
* Metastases or active other cancer (defined by malignancy in<5 year, excluding curatively treated CIS cervix, Stage 1/grade 1 endometrium carcinoma or successfully treated non-melanoma skin 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 over more than 1 cm2
* Inability to read Dutch

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Occurrence of teleangiectasia, following Bentzen's four point scale (LENTSOMA),<br /><br>after 2 years.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Local recurrence, disease free and overall survival<br /><br>Side effects/ adverse events( including<br /><br>o Pain (acute and late) (LENTSOMA)<br /><br>o Redness<br /><br>o Skin induration (acute or late CTCAE 4.03):<br /><br>o Radiation dermatitis (acute) RTOG/EORTC ánd CTCAE 4.03:<br /><br>o Subcutaneaous induration (late ) RTOG/EORTC<br /><br>o Pigmentation (acute and late) LENTSOMA/Bentzen :<br /><br>o Surgical Site Infection (Acute) CDC<br /><br>Cosmetic and functional results<br /><br>Health related Quality of Life<br /><br>Cost effectiveness<br /><br>Validation of a Dutch translation of the BCTOS questionnaire<br /><br>Skin dose </p><br>