Understanding breast cancer-related lymphedema
Early Diagnosis of Breast Cancer-related Lymphedema
Kaohsiung Veterans General Hospital. · NCT06046365
This study is trying to understand what causes swelling in the arms of women after breast cancer surgery by using special imaging techniques to look at how lymphatic fluid moves and how the tissues feel.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | Female |
| Sponsor | Kaohsiung Veterans General Hospital. (other) |
| Locations | 1 site (Kaohsiung City) |
| Trial ID | NCT06046365 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the mechanisms behind upper limb lymphedema following breast cancer surgery. It will recruit female patients who have undergone or are expected to undergo breast cancer resection and utilize various advanced imaging techniques, including Indocyanine Green lymphography and Lymphoscintigraphy, to identify lymphatic blockages. Additionally, Shear Wave Elastography will assess tissue compliance, while DXA body composition analysis will compare limb composition ratios. The study seeks to explore the relationships among lymphatic circulation, limb circumference, tissue compliance, and blood flow changes.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 20 to 80 who have undergone or are scheduled for breast cancer surgery.
Not a fit: Patients with unhealed wounds, significant cognitive impairments, or upper limb functional abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of lymphedema in breast cancer patients.
How similar studies have performed: While there is ongoing research in this area, this study's specific combination of techniques and focus on early detection represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kaohsiung City
- Kaohsiung Veterans General Hospital — Kaohsiung City, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Zheng Yu Hoe
- Email: jhoe@vghks.gov.tw
- Phone: +886935517631
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lymphedema, lymphoedema, limb circumference, tissue hardness