Lymphedema Screening
Overview
Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, there is no established screening program for lymphedema. This cross-sectional study will investigate diagnostic modalities in screening for lymphedema in patients with and without known lymphedema after breast cancer.
Full Title of Study: “Screening for Lymphedema”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: October 2021
Interventions
- Diagnostic Test: Circumference tape measurements
- centimeter and volume criterias
- Diagnostic Test: Indocyanine green lymphangiography
- Presence of dermal backflow
- Diagnostic Test: bioimpedance spectroscopy
- 7.5 and 10 L-DEX criterias
- Diagnostic Test: Symptom score
- using lymph-icf, DASH and SF-36 questionnaires
Arms, Groups and Cohorts
- Other: Breast cancer patients with lymphedema
- Other: Breast cancer patients without lymphedema
Clinical Trial Outcome Measures
Primary Measures
- sensitivity, specificy, NPV and PPV
- Time Frame: through study completion, approximately 1 year
- diagnosotic statistics of lymphedema measurements
Participating in This Clinical Trial
Inclusion Criteria
- Previous breast cancer treated with axillary lymph node dissection – No recurrence – Understand the study – Can talk, read and understand Danish Exclusion Criteria:
- Pregnant or breast feeding – Lymph node dissection from other basins – Psychiatric disorder – Not possible to perform indocyanine green lymphangiography
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Odense University Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Mads Gustaf Jørgensen, Principal Investigator – Odense University Hospital
- Overall Contact(s)
- Mads G Jørgensen, MD, 29210114, Mads.Gustaf.Jorgensen@rsyd.dk
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