Early Diagnosis of Breast Cancer-related Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- circumference
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
circumference
时间窗: everyday, through study completion, an average of 1 year
Circumference measurements are taken and recorded at 2 cm intervals from the wrist crease to the armpit on both upper limbs
DXA body composition analysis
时间窗: Once at the beginning of the study, and another assessment will be conducted 3 months later if there is a deterioration in lymphedema
Using DXA to detect and compare the composition of both limbs at different stages after the onset of lymphedema, including changes in protein, fat, and mineral density
Tissue compliance
时间窗: every 1 week, through study completion, an average of 1 year
Measurements are taken every 5 cm from the wrist crease to the armpit on both upper limbs using ShearWave Elastography
Lymphoscintigraphy
时间窗: Once at the beginning of the study, and another assessment will be conducted six months later if there is a deterioration in lymphedema
Golden Standard for diagnosing lymphedema, used for detecting the location of lymphatic circulation blockage
Indocyanine green (ICG) lymphography
时间窗: Once at the beginning of the study, and another assessment will be conducted 3 months later if there is a deterioration in lymphedema
Routine examination, used for detecting the type of lymphatic blockage
次要结局
未报告次要终点
研究者
Zheng-Yu Hoe, MD., PhD.
Chairperson
Kaohsiung Veterans General Hospital.