Early Diagnosis of Breast Cancer-related Lymphedema
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Zheng Yu Hoe
- Phone Number: +886935517631
- Email: jhoe@vghks.gov.tw
Study Locations
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Kaohsiung, Taiwan, 81362
- Recruiting
- Kaohsiung Veterans General Hospital
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Contact:
- Zheng-Yu Hoe
- Phone Number: +886975581721
- Email: jhoe@vghks.gov.tw
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Principal Investigator:
- Zheng-Yu Hoe
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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mastectomy
Expected to include female patients who are undergoing breast cancer resection surgery or those who have already undergone breast resection surgery for breast cancer.
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lymphoscintigraphy
circumference measurement
B-mode sono and elastography
DXA body composition analysis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
circumference
Time Frame: 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
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everyday, through study completion, an average of 1 year
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Tissue compliance
Time Frame: every 1 week, through study completion, an average of 1 year
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Measurements are taken every 5 cm from the wrist crease to the armpit on both upper limbs using ShearWave Elastography
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every 1 week, through study completion, an average of 1 year
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Lymphoscintigraphy
Time Frame: Once at the beginning of the study, and another assessment will be conducted six months later if there is a deterioration in lymphedema
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Golden Standard for diagnosing lymphedema, used for detecting the location of lymphatic circulation blockage
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Once at the beginning of the study, and another assessment will be conducted six months later if there is a deterioration in lymphedema
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Indocyanine green (ICG) lymphography
Time Frame: Once at the beginning of the study, and another assessment will be conducted 3 months later if there is a deterioration in lymphedema
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Routine examination, used for detecting the type of lymphatic blockage
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Once at the beginning of the study, and another assessment will be conducted 3 months later if there is a deterioration in lymphedema
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DXA body composition analysis
Time Frame: Once at the beginning of the study, and another assessment will be conducted 3 months later if there is a deterioration in lymphedema
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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
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Once at the beginning of the study, and another assessment will be conducted 3 months later if there is a deterioration in lymphedema
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-CT2-15(211230-3)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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