Early Diagnosis of Breast Cancer-related Lymphedema
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| ClinicalTrials.gov Identifier: NCT06046365 |
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Recruitment Status :
Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
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| Condition or disease | Intervention/treatment |
|---|---|
| Lymphedema | Diagnostic Test: lymphoscintigraphy Diagnostic Test: circumference measurement Diagnostic Test: sonography Diagnostic Test: DXA body composition analysis |
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 : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Early Diagnosis of Breast Cancer-related Lymphedema |
| Actual Study Start Date : | January 1, 2022 |
| Estimated Primary Completion Date : | December 2024 |
| Estimated Study Completion Date : | December 2024 |
| 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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Diagnostic Test: lymphoscintigraphy
lymphoscintigraphy Diagnostic Test: circumference measurement circumference measurement Diagnostic Test: sonography B-mode sono and elastography Diagnostic Test: DXA body composition analysis DXA body composition analysis |
- 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
- Tissue compliance [ Time Frame: 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 [ 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 ]Golden Standard for diagnosing lymphedema, used for detecting the location of lymphatic circulation blockage
- 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 ]Routine examination, used for detecting the type of lymphatic blockage
- 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 ]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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| Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06046365
| Contact: Zheng Yu Hoe | +886935517631 | jhoe@vghks.gov.tw |
| Taiwan | |
| Kaohsiung Veterans General Hospital | Recruiting |
| Kaohsiung, Taiwan, 81362 | |
| Contact: Zheng-Yu Hoe +886975581721 jhoe@vghks.gov.tw | |
| Principal Investigator: Zheng-Yu Hoe | |
| Responsible Party: | Zheng-Yu Hoe, MD., PhD., Chairperson, Kaohsiung Veterans General Hospital. |
| ClinicalTrials.gov Identifier: | NCT06046365 |
| Other Study ID Numbers: |
22-CT2-15(211230-3) |
| First Posted: | September 21, 2023 Key Record Dates |
| Last Update Posted: | September 21, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | There is not a plan to make IPD available |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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lymphoedema limb circumference tissue hardness |
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Lymphedema Breast Cancer Lymphedema Lymphatic Diseases Postoperative Complications Pathologic Processes |