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Extracellular Fluid Changes During Neoadjuvant Chemotherapy

NCT07315880 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 111

Last updated 2026-02-24

No results posted yet for this study

Summary

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

  • Lymphedema Arm

Sponsors & Collaborators

  • Florence Nightingale Hospital, Istanbul

    lead OTHER

Principal Investigators

  • Zeynep Erdoğan İyigün, Prof · Bahçeşehir Üniversitesi

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2025-05-31
Completion
2025-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07315880 on ClinicalTrials.gov