RecruitingNCT06046365

Early Diagnosis of Breast Cancer-related Lymphedema

Sponsor

Kaohsiung Veterans General Hospital.

Enrollment

300 participants

Start Date

Oct 24, 2022

Study Type

OBSERVATIONAL

Conditions

Lymphedema

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.

Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 80 Years

Inclusion Criteria5

Female patients who are expected to undergo breast cancer resection surgery or have already undergone breast resection surgery for breast cancer.
Absence of unhealed open wounds or other conditions unsuitable for tactile measurements within the measurement area.
No severe cognitive or emotional impairments.
No substance abuse (alcohol or drugs).
Females aged between 20 and 80, capable of fully complying with the requirements of this study plan.

Exclusion Criteria4

Presence of unhealed open wounds or other conditions unsuitable for tactile measurements within the measurement area.
Upper limb abnormalities in function (including joint mobility and muscle strength).
Significant cognitive, auditory, or expressive language issues that hinder comprehension and compliance with instructions.
Lack of assistance for daily measurements.