Early Diagnosis of Breast Cancer-related Lymphedema

Lymphedema Clinical Trial

Official title:

Early Diagnosis of Breast Cancer-related Lymphedema

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06046365
• Other study ID #: 22-CT2-15(211230-3)
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Kaohsiung Veterans General Hospital.
• Contact: Zheng Yu Hoe
• Phone: +886935517631
• Email: jhoe[@]vghks.gov.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Lymphedema

Intervention

Diagnostic Test:
• lymphoscintigraphy
lymphoscintigraphy
• circumference measurement
circumference measurement
• sonography
B-mode sono and elastography
• DXA body composition analysis
DXA body composition analysis

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	circumference	Circumference measurements are taken and recorded at 2 cm intervals from the wrist crease to the armpit on both upper limbs	everyday, through study completion, an average of 1 year
Primary	Tissue compliance	Measurements are taken every 5 cm from the wrist crease to the armpit on both upper limbs using ShearWave Elastography	every 1 week, through study completion, an average of 1 year
Primary	Lymphoscintigraphy	Golden Standard for diagnosing lymphedema, used for detecting the location of lymphatic circulation blockage	Once at the beginning of the study, and another assessment will be conducted six months later if there is a deterioration in lymphedema
Primary	Indocyanine green (ICG) lymphography	Routine examination, used for detecting the type of lymphatic blockage	Once at the beginning of the study, and another assessment will be conducted 3 months later if there is a deterioration in lymphedema
Primary	DXA body composition analysis	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	Once at the beginning of the study, and another assessment will be conducted 3 months later if there is a deterioration in lymphedema