Extracellular Fluid Changes During Neoadjuvant Chemotherapy

NCT07315880 | Completed

• 1 other identifier: FNH2025-2
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

breast neoplasm; lymphedema; neoadjuvant chemotherapy; breast cancer related lymphedema; extracellular fluid accumulation

Outcome Measures

Primary Outcomes (1)

• Change in Extravascular (Extracellular) Fluid of the Upper Extremity

  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.

  Baseline (pre-NACT) to two weeks after completion of neoadjuvant chemotherapy

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females with breast cancer diagnosis
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult 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 enrollment. The population includes patients with varying tumor stages and molecular subtypes, including HER2-positive and triple-negative breast cancer. All participants are capable of undergoing bioimpedance spectroscopy (BIS) and arm circumference measurements for the assessment of extravascular fluid changes and subclinical lymphedema.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florence Nightingale Hospital, Istanbul: lead

Study Sites (1)

Istanbul Florence Nightingale Hospital, Breast Health Center

Istanbul, Sisli, 34381, Turkey (Türkiye)

Location

Related Publications (2)

• Swaroop 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 BACKGROUND

• Semb 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 BACKGROUND

Related Links

• The Diagnosis and Treatment of Peripheral Lymphedema: 2023 Consensus Document of The International Society of Lymphology
• Impact of adjuvant taxane-based chemotherapy on development of breast cancer-related lymphedema: results from a large prospective cohort
• Evaluation of Long-Term Lymphedema Rate in Patients With Subclinical Lymphedema Diagnosed in the Preoperative Period via Bioimpedance
• L-dex ratio in detecting breast cancer-related lymphedema: reliability, sensitivity, and specificity
• Bioimpedance spectroscopy for breast cancer-related lymphedema assessment: clinical practice guidelines
• Lymphedema following taxane-based chemotherapy in women with early breast cancer
• Treatment factors affecting breast cancer-related lymphedema after systemic chemotherapy and radiotherapy in stage II/III breast cancer patients

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zeynep Erdoğan İyigün, Prof

  Bahçeşehir Üniversitesi

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 5, 2026
• Study Start: January 1, 2021
• Primary Completion: May 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 24, 2026

Record last verified: 2025-12

Locations

TU (1)