Clinical trial · Observational
Extracellular Fluid Changes During Neoadjuvant Chemotherapy
Extracellular Fluid Changes During Neoadjuvant Chemotherapy in Breast Cancer: A Prospective Bioimpedance Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema Arm | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Breast cancer patients receiving standard neoadjuvant chemotherapy prior to surgery
- description
- 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.
Primary outcomes (1)
- measure
- Change in Extravascular (Extracellular) Fluid of the Upper Extremity
- timeFrame
- Baseline (pre-NACT) to two weeks after completion of neoadjuvant chemotherapy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDSwaroop MN, Ferguson CM, Horick NK, Skolny MN, Miller CL, Jammallo LS, Brunelle CL, O'Toole JA, Isakoff SJ, Specht MC, Taghian AG. Impact of adjuvant taxane-based chemotherapy on development of breast cancer-related lymphedema: results from a large prospective cohort. Breast Cancer Res Treat. 2015 Jun;151(2):393-403. doi: 10.1007/s10549-015-3408-1. Epub 2015 May 5. PMID 25940996
- BACKGROUNDSemb KA, Aamdal S, Oian P. Capillary protein leak syndrome appears to explain fluid retention in cancer patients who receive docetaxel treatment. J Clin Oncol. 1998 Oct;16(10):3426-32. doi: 10.1200/JCO.1998.16.10.3426. PMID 9779722