The purpose of this prospective clinical study is to evaluate whether neoadjuvant chemotherapy (NACT) is associated with an increase in extravascular (extracellular) fluid in the ipsilateral upper extremity, an early indicator of breast cancer-related lymphedema (BCRL), in patients with newly diagnosed breast cancer who have not yet undergone breast surgery or axillary lymph node dissection.
Adult patients with a new diagnosis of breast cancer for whom standard NACT is planned will undergo baseline assessments prior to initiation of chemotherapy and follow-up assessments approximately two weeks after completion of NACT. Extravascular fluid status will be evaluated using bioimpedance spectroscopy (L-Dex) and standardized upper extremity circumference measurements.
The primary objective is to assess within-subject changes in extracellular fluid following NACT. Secondary objectives include evaluating the frequency of extracellular fluid increase and exploring associations between extracellular fluid changes and selected patient- and disease-related characteristics, such as age, clinical nodal status, molecular subtype, body mass index, hormone receptor status, and receipt of targeted therapy.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patients aged 18 years or older.
* Histologically confirmed diagnosis of breast cancer.
* Planned to receive standard neoadjuvant chemotherapy (NACT) prior to surgery.
* Patients who agreed to participate in the study.
* No contraindications to bioimpedance spectroscopy (BIS), including implanted electronic devices, open wounds or infections on the measurement site, pregnancy, severe non-cancer-related edema, or inability to maintain a supine position during measurement.
Exclusion Criteria:
* Presence of clinically detectable lymphedema at baseline.
* Incomplete or discontinued chemotherapy for any reason.
* Receiving non-standard chemotherapy regimens outside the study protocol.
* Any medical condition or device that prevents accurate BIS measurement.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Extravascular (Extracellular) Fluid of the Upper Extremity
Timeframe: Baseline (pre-NACT) to two weeks after completion of neoadjuvant chemotherapy