NCT06046365 Early Diagnosis of Breast Cancer-related Lymphedema
| NCT ID | NCT06046365 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kaohsiung Veterans General Hospital. |
| Condition | Lymphedema |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-10-24 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2022-10-24 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06046365 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 80 Years, studying Lymphedema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06046365 currently recruiting?
Yes, NCT06046365 is actively recruiting participants. Contact the research team at jhoe@vghks.gov.tw for enrollment information.
Where is the NCT06046365 trial being conducted?
This trial is being conducted at Kaohsiung City, Taiwan.
Who is sponsoring the NCT06046365 clinical trial?
NCT06046365 is sponsored by Kaohsiung Veterans General Hospital.. The trial plans to enroll 300 participants.