Clinical trial NCT06046365: Early Diagnosis of Breast Cancer-related Lymphedema
Official title: Early Diagnosis of Breast Cancer-related Lymphedema
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphedema
Keywords: lymphoedema
limb circumference
tissue hardness
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study aims to recruit 100 breast cancer patients (those who have previously undergone or are expected to undergo any form of breast resection surgery) for research purposes.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: circumference
timeFrame: everyday, through study completion, an average of 1 year
measure: Tissue compliance
timeFrame: every 1 week, through study completion, an average of 1 year
measure: Lymphoscintigraphy
timeFrame: Once at the beginning of the study, and another assessment will be conducted six months later if there is a deterioration in lymphedema
measure: Indocyanine green (ICG) lymphography
timeFrame: Once at the beginning of the study, and another assessment will be conducted 3 months later if there is a deterioration in lymphedema
measure: DXA body composition analysis
timeFrame: Once at the beginning of the study, and another assessment will be conducted 3 months later if there is a deterioration in lymphedema
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
References: