Lymphedema Screening (LymphScreen)

Odense University Hospital

Status: Unknown

Conditions: Lymphedema

Treatments: Diagnostic Test: Circumference tape measurements; Diagnostic Test: Indocyanine green lymphangiography; Diagnostic Test: Symptom score; Diagnostic Test: bioimpedance spectroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT04606511

S-20200094

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Breast cancer patients with lymphedema

Other group

Treatment:

Diagnostic Test: bioimpedance spectroscopy

Diagnostic Test: Symptom score

Diagnostic Test: Indocyanine green lymphangiography

Diagnostic Test: Circumference tape measurements

Breast cancer patients without lymphedema

Other group

Treatment:

Diagnostic Test: bioimpedance spectroscopy

Diagnostic Test: Symptom score

Diagnostic Test: Indocyanine green lymphangiography

Diagnostic Test: Circumference tape measurements