Early Diagnosis of Breast Cancer-related Lymphedema

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест lymphoscintigraphy
  lymphoscintigraphy
• Диагностический тест circumference measurement
  circumference measurement
• Диагностический тест sonography
  B-mode sono and elastography
• Диагностический тест DXA body composition analysis
  DXA body composition analysis

Первичные конечные точки

• circumference [Срок оценки: everyday, through study completion, an average of 1 year]
• Tissue compliance [Срок оценки: every 1 week, through study completion, an average of 1 year]
• Lymphoscintigraphy [Срок оценки: Once at the beginning of the study, and another assessment will be conducted six months later if there is a deterioration in lymphedema]
• Indocyanine green (ICG) lymphography [Срок оценки: Once at the beginning of the study, and another assessment will be conducted 3 months later if there is a deterioration in lymphedema]
• DXA body composition analysis [Срок оценки: Once at the beginning of the study, and another assessment will be conducted 3 months later if there is a deterioration in lymphedema]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Тайвань · 1 центр

• Kaohsiung Veterans General Hospital — Kaohsiung City

Идентификаторы

NCT: NCT06046365 · 22-CT2-15(211230-3)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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