Lymphoedema in breast cancer patients Circulatory System
Conditions
Interventions
Observational: Patients are included after breast cancer diagnosis but before start of treatment. A baseline visit is performed with assessment of arm volume, bioimpedance, biomarkers, genetics, patie
Sponsors
Uppsala University Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Females age 18 years or older 2. Diagnosis of invasive breast cancer 3. Planned breast cancer treatment at Uppsala University Hospital 4. Informed written consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. 2. Previous diagnosis of lymphoedema in the upper extremity 3. Previous bilateral radiotherapy treatment for diagnosis other than breast cancer (ipsilateral radiotherapy is not an exclusion criterion, i.e. same side as current breast cancer diagnosis) 4. Previous chemotherapy for a malignant diagnosis other than breast cancer within 12 months prior to breast cancer diagnosis 5. Previous axillary surgery for diagnosis other than breast cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of lymphoedema is determined through repeated measures of volume with infrared light measuring the outer limits of the upper extremity and percentage water content and tissue dielectric constant through bioimpedance spectroscopy at 3, 6, 12, 24, 36 months with pathological values indicating lymphoedema diagnosis validated by indocyanine green injection (ICG) and assessment of disrupted lymphatic flow through near-infrared light examination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Genetic variations assessed through genome genome-wide association study at the end of follow-up 2. Received treatment and risk correlation to lymphoemdea at the end of follow-up 3. Lymphatic anatomical variations assessed through ICG at baseline and 12 months 4. Quality of life assessed through questionnaires at baseline, 6, 12 and 36 months 5. Biomarker variations assessed through multiplex immunoassay at baseline, 6, 12, 24 and 36 months | — |
Countries
Sweden
Contacts
Public ContactMaria Mani
Outcome results
None listed