Breast Neoplasms, Lymphedema Due to Radiation
Conditions
Brief summary
The goal of this observational study is to learn how the lymphatic system changes before and after radiotherapy in female patients with breast cancer. The study aims to understand early lymphatic changes that may lead to breast-cancer-related lymphedema (BCRL) and to help identify patients who might benefit from early preventive rehabilitation. The main questions it aims to answer are: How does lymphatic flow and vessel function change after radiotherapy, as measured by indocyanine green (ICG) lymphography? Can early imaging changes on ICG lymphography predict later swelling or lymphedema symptoms in the arm? There is no comparison or treatment group, since all participants will receive radiotherapy as part of their standard breast cancer care. Participants will: Undergo ICG lymphography before radiotherapy and again within 4-6 weeks after completing radiotherapy Receive a small injection of ICG dye under the skin and have near-infrared imaging to visualize lymphatic flow Complete follow-up assessments (for some participants) at 3, 6, or 12 months to monitor long-term lymphatic changes Continue their usual standard medical and rehabilitation care throughout the study This study will include 40 female participants, aged 18 years or older, who have been diagnosed with stage I-III breast cancer and are scheduled for postoperative radiotherapy. Participants with a history of lymphedema, prior radiotherapy, severe organ disease, or known ICG/iodine allergy will not be included. The information collected will include imaging findings from ICG lymphography, arm circumference and volume measurements, and patient-reported outcomes on arm discomfort or swelling. These data will help researchers identify early imaging biomarkers of radiation-induced lymphatic dysfunction. The study does not involve any experimental treatment or random assignment. All procedures are routine diagnostic or rehabilitation methods that are already approved for clinical use. The ICG test uses a very small amount of dye and is considered safe, with allergic reactions being rare. The findings of this study may provide new insights into how radiotherapy affects the lymphatic system and may contribute to developing personalized strategies to prevent or minimize lymphedema after breast cancer treatment.
Interventions
None listed
Sponsors
Inah Kim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female, ≥18 years old * Pathologically confirmed stage I-III breast cancer * Scheduled to receive postoperative radiotherapy (RT)
Exclusion criteria
* Previous or current lymphedema * Prior radiotherapy to the ipsilateral breast or axilla * History of neoadjuvant chemotherapy * Severe systemic diseases (heart, renal, hepatic failure) * Active infection * Pregnancy or lactation Allergy to indocyanine green (ICG) or iodine-based contrast agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lymphatic Function Before and After Radiotherapy Measured by ICG Lymphography | Baseline (before radiotherapy), 4-6 weeks after completion of radiotherapy, and optionally at 3, 6, and 12 months after RT completion if follow-up imaging is performed. | Changes in lymphatic function assessed by indocyanine green (ICG) lymphography before and after radiotherapy (RT) including paired T0-to-T1 change in breast indocyanine green (ICG) stage. This reflect radiation-induced lymphatic dysfunction and may serve as early imaging biomarkers for breast-cancer-related lymphedema (BCRL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Arm Circumference and Limb Volume After Radiotherapy | Baseline (before radiotherapy), 4-6 weeks, and optionally at 3, 6, and 12 months after RT completion | Change in limb volume (using the truncated cone formula) before and after radiotherapy (RT), compared with baseline measurements. These measurements will be used to determine whether early lymphatic imaging changes are correlated with the development or progression of breast-cancer-related lymphedema (BCRL). |
Countries
South Korea
Contacts
CONTACTInah Kim, M.D.,Ph.D
CONTACTYongkyun Jung, M.D.
Outcome results
None listed