Breast Cancer Clinical Trial
— AREOLA-BOfficial title:
Association of Silicone Breast Implant Reconstruction and -Enlargement With Overall Wellbeing, Lymphoma and Auto-immune Disease - Breast Implant Illness
Verified date | April 2023 |
Source | The Netherlands Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background: Implant-based breast reconstructions contribute considerably to the quality of life of breast cancer patients. A knowledge gap exists concerning the potential role of breast implants in the development of so called 'breast implant illness' and autoimmune diseases in breast cancer survivors with a silicone breast implant-based reconstruction. Breast implant illness is a constellation of non-specific symptoms reported by a small group of women with silicone breast implants. Methods/Design: The Areola study is a multi-centre historic cohort study with prospective follow-up aiming to assess the risk of 'breast implant illness' and autoimmune diseases in female breast cancer survivors with and without silicone breast implants. The cohort consists of breast cancer survivors who received surgical treatment with silicone implant-based reconstruction in six major hospitals across the Netherlands in the period between 2000 and 2015. As comparison group, a frequency-matched sample of breast cancer survivors without breast implants will be selected. An additional group of women who received breast augmentation surgery in the same years will be selected to compare their characteristics and health outcomes with those of breast cancer patients with implants. All women still alive will be invited to complete a web-based questionnaire covering various health related topics. The entire cohort including deceased women will be linked to the population based computerized databases of Statistics Netherlands. These databases include a registry of diagnostic codes, a pharmacotherapeutic prescriptions registry and a cause-of-death registry in which diagnoses of autoimmune diseases will be identified. Outcomes of interest are the prevalence and incidence of BII and the prevalence and incidence of autoimmune diseases. In addition, risk factors for the development of BII and autoimmune disorders will be assessed among women with implants. Discussion: The Areola study will contribute to the availability of reliable information on the risks of breast implant illness and autoimmune diseases in Dutch breast cancer survivors with silicone breast implants. This will inform breast cancer survivors and aid future breast cancer patients and their treating physicians to make informed decisions about reconstructive strategies after mastectomy. Keywords: Silicone breast implants, Breast reconstruction, Breast cancer, Breast Implant Illness, Autoimmune disease
Status | Enrolling by invitation |
Enrollment | 15000 |
Est. completion date | June 1, 2025 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - surgery for first invasive breast cancer or ductal carcinoma in situ (DCIS) in the years 2000 to 2015 in the collaborating centres Exclusion Criteria: - above the age of 60 at breast cancer diagnosis - above the age of 80 years at time of inclusion - Not residing in Netherlands |
Country | Name | City | State |
---|---|---|---|
Netherlands | Ziekenhuisgroep Twente | Almelo | Overijssel |
Netherlands | Netherlands Cancer Institute Antoni van Leeuwenhoek | Amsterdam | Noord-Holland |
Netherlands | Medisch Spectrum Twente | Enschede | Overijssel |
Netherlands | Zuyderland Medical Center | Heerlen | Limburg |
Netherlands | Velthuis Kliniek | Hilversum | Noord-Holland |
Netherlands | Maastricht University Medical Center | Maastricht | Limburg |
Netherlands | Erasmus MC University Medical Center | Rotterdam | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
The Netherlands Cancer Institute | Erasmus Medical Center, Maastricht University Medical Center, Medisch Spectrum Twente, Velthuis Kliniek, Ziekenhuisgroep Twente, Zuyderland Medical Centre |
Netherlands,
Spoor J, de Jong D, van Leeuwen FE. [Silicone breast implants: the importance of nuanced reporting]. Ned Tijdschr Geneeskd. 2022 Mar 21;166:D6515. Dutch. — View Citation
Spoor J, de Jong D, van Leeuwen FE. Silicone Particle Migration: A Misleading Report. Aesthet Surg J. 2022 Mar 15;42(4):NP261-NP262. doi: 10.1093/asj/sjab377. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Breast Implant Illness | Relative risk (RR) of experiencing the following complaints in exposed and comparison groups:
Cognitive impairment joint pain myalgia anxiety feeling depressed skin rashes weakness sleeping problems headache hair loss food intolerances and allergies numbness/tingling in upper and lower limbs dry eyes morning stiffness night sweats heart palpitations shoulder pain |
20years | |
Primary | Autoimmune disease | Relative risk (RR) and Incidence rate (IR) for the following illnesses in exposed group and comparison group:
Sjögren's Syndrome (SjS) Rheumatoid Arthritis (RA) Systemic Lupus Erythematosus (SLE) Systemic Sclerosis (SSc), Mixed Connective Tissue Disease (MCTD) Antiphospholipid Syndrome (APS) Ankylosing Spondylitis Sarcoidosis Multiple Sclerosis (MS) hypothyroidism hyperthyroidism psoriatic disease inflammatory bowel disease fibromyalgia chronic fatigue syndrome irritable bowel syndrome |
20years | |
Primary | Relative risk to develop autoimmune diseases and BII complaints associated with certain risk factors: | RR for BII and autoimmune diseases will be assessed associated with riskfactors in the domains of demographics, lifestyle, reproductive history, medical- and treatment history and family history. Furthermore the influence of psychosocial factors like satisfaction with the breasts and self-esteem on BII risk are evaluated. | 20years |
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