Extracellular Fluid Changes During Neoadjuvant Chemotherapy in Breast Cancer: A Prospective Bioimpedance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Change in Extravascular (Extracellular) Fluid of the Upper Extremity
研究概览
简要总结
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.
详细描述
Breast cancer-related lymphedema (BCRL) is a chronic condition that can adversely affect upper extremity function and quality of life. Although BCRL is traditionally regarded as a postoperative complication related to axillary surgery or radiotherapy, accumulating evidence suggests that lymphatic dysfunction and extracellular fluid accumulation may begin earlier in the treatment course, including during neoadjuvant chemotherapy (NACT). Identifying such early, subclinical changes may enable timely preventive strategies.
This prospective, single-center clinical study is designed to evaluate whether neoadjuvant chemotherapy (NACT) is associated with an increase in extravascular (extracellular) fluid in the ipsilateral upper extremity among patients with newly diagnosed breast cancer who have not yet undergone breast surgery or axillary lymph node dissection.
The study was initiated on January 1, 2021, with a planned completion date of December 31, 2025. All participants are recruited and followed at the Istanbul Florence Nightingale Hospital Breast Health Center.
Eligible participants are adult women (≥18 years) with histologically confirmed breast cancer who are scheduled to receive standard NACT. Patients with prior breast or axillary surgery, preexisting clinical lymphedema, incomplete chemotherapy, or non-standard treatment regimens are not included.
Each participant undergoes two standardized assessment visits: a baseline evaluation conducted prior to initiation of NACT and a post-treatment evaluation performed approximately two weeks after completion of NACT and before definitive breast surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Breast cancer patients receiving standard neoadjuvant chemotherapy prior to surgery
This group includes female patients diagnosed with breast cancer who are planned to receive standard neoadjuvant chemotherapy (NACT) prior to any surgical intervention. Participants have not yet undergone breast surgery or axillary lymph node dissection at the time of enrollment. The group will be assessed for early changes in extravascular (extracellular) fluid and subclinical lymphedema using bioimpedance spectroscopy (L-Dex) and arm circumference measurements before and after completion of NACT. All participants follow the same chemotherapy protocol, which may include anthracyclines, cyclophosphamide, paclitaxel, and, if HER2-positive, trastuzumab and pertuzumab.
结局指标
主要结局
Change in Extravascular (Extracellular) Fluid of the Upper Extremity
时间窗: Baseline (pre-NACT) to two weeks after completion of neoadjuvant chemotherapy
The primary outcome is the quantitative change in extracellular fluid in the treated upper extremity, measured using bioimpedance spectroscopy (L-Dex U400®) and arm circumference measurements. An increase of ≥6.5 L-Dex units from baseline is considered indicative of subclinical lymphedema.
次要结局
未报告次要终点
研究者
Enver Özkurt
Assoc. Prof. Dr.
Florence Nightingale Hospital, Istanbul