NCT06046365

Early Diagnosis of Breast Cancer-related Lymphedema

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Kaohsiung Veterans General Hospital. · Academic / Other
• Sex: Female
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will conduct clinical trials to explore the mechanisms behind the development of upper limb lymphedema following breast cancer surgery. The investigators will recruit patients who have undergone breast cancer surgery and utilize Indocyanine Green (ICG) lymphography and Lymphoscintigraphy to identify the locations of lymphatic blockages. Shear Wave Elastography (SWE) will be used to detect changes in tissue limb compliance. DXA body composition analysis will measure the differences in the composition ratios between edematous and normal limbs. In addition, diffusion correlation spectrometry will be employed to monitor changes in deep tissue blood flow, complemented by continuous measurements of limb circumference and other physiological parameters. The study aims to explore the interrelationships among lymphatic circulation, limb circumference, tissue compliance, and tissue blood flow rates.

Detailed description

Breast cancer ranks as the most common cancer among women in Taiwan. According to the cancer registry data of Taiwan's Ministry of Health and Welfare, there were 16,325 new cases of breast cancer in 2016. Approximately one in 12 women will develop breast cancer in her lifetime. Although the incidence rate is high, the survival rate after clinical treatment is also quite high. The five-year survival rate for early-stage breast cancer patients exceeds 90%, making it a highly manageable disease at present. The incidence rate of breast cancer-related lymphedema is around 21.4%, and is expected to become increasingly common as the survival rate of patients improves. Aside from causing psychological distress, it also impairs a patient's work and daily life capabilities. Patients also have to bear additional medical expenses, which brings a significant financial burden to families. Current research supports that early detection and treatment are key to controlling breast cancer-related lymphedema. However, there is still a need for a clearer understanding of the risk factors causing lymphedema and the physiological changes that occur when it manifests, in order to achieve the goal of early detection. This study will conduct clinical trials to investigate the mechanisms of upper limb lymphedema after breast cancer surgery. The investigators will recruit post-operative breast cancer patients and use Indocyanine Green (ICG) lymphography and Lymphoscintigraphy to detect lymphatic blockage locations; Shear Wave Elastography (SWE) to detect changes in tissue limb compliance; DXA body composition analysis to measure the differences in edema and normal limb composition ratios; and diffusion correlation spectrometry to measure deep tissue blood flow changes, along with continuous measurements of limb circumference and other physiological parameters. The study aims to explore the interrelationship among lymphatic circulation, limb circumference, tissue compliance, and tissue blood flow. The expected results of this study can help the investigators understand the risk factors causing lymphedema and the physiological changes that occur when it manifests, overcome the current difficulties in early lymphedema detection, and develop effective monitoring methods and equipment. This will provide more possibilities for the early detection and treatment of future patients with breast cancer-related lymphedema.

Conditions

• Lymphedema

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	lymphoscintigraphy	lymphoscintigraphy
DIAGNOSTIC_TEST	circumference measurement	circumference measurement
DIAGNOSTIC_TEST	sonography	B-mode sono and elastography
DIAGNOSTIC_TEST	DXA body composition analysis	DXA body composition analysis

Timeline

• Start date: 2022-10-24
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-09-21
• Last updated: 2025-06-11

Locations

1 site across 1 country: Taiwan