Lymphedema ArmNCT07315880
Extracellular Fluid Changes During Neoadjuvant Chemotherapy
An observational study of Lymphedema Arm, run by Florence Nightingale Hospital, Istanbul at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema Arm
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 31 Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Florence Nightingale Hospital, Breast Health Center
Istanbul, Sisli, 34381
About this study
Official title: Extracellular Fluid Changes During Neoadjuvant Chemotherapy in Breast Cancer: A Prospective Bioimpedance Study
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.
Read the detailed description
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.
At both visits, segmental bioimpedance spectroscopy using the L-Dex U400® device and upper extremity circumference measurements are performed following standardized procedures. For bioimpedance spectroscopy, two consecutive measurements are obtained and averaged to generate the L-Dex score. Arm circumferences are measured at 5-cm intervals along the upper limb, with three measurements averaged at each point. All assessments are conducted by the same trained clinician to ensure measurement consistency.
The standard neoadjuvant chemotherapy regimen consists of four cycles of intravenous doxorubicin (60 mg/m²) and cyclophosphamide (600 mg/m²) administered every 21 days, followed by weekly paclitaxel (80 mg/m²) for 12 weeks. Patients with HER2-positive disease receive trastuzumab and pertuzumab according to standard loading and maintenance dosing schedules concurrently with paclitaxel therapy.
The study evaluates changes in extracellular fluid status using bioimpedance spectroscopy and arm circumference measurements, and explores associations between these changes and selected patient- and disease-related characteristics.
- Conditions
- Lymphedema Arm
- Keywords
- breast neoplasm, lymphedema, neoadjuvant chemotherapy, breast cancer related lymphedema, extracellular fluid accumulation
- Medical subject headings
- Breast Neoplasms, Lymphedema, Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-NACT) to two weeks after completion of neoadjuvant chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Jan 2021
- Primary completion31 May 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lymphedema ArmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Florence Nightingale Hospital, Istanbul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enver Özkurt, Florence Nightingale Hospital, Istanbul
- Investigators
- Zeynep Erdoğan İyigün, Prof, Study chair, Bahçeşehir Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315880
- Sponsor's protocol ID
- FNH2025-2
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time, the plan for sharing individual participant data (IPD) has not been finalized. Decisions regarding data sharing will depend on future considerations, including participant privacy, ethical approvals, and institutional policies.
Publications
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.
PubMed 25940996Semb 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.
PubMed 9779722
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracellular Fluid Changes During Neoadjuvant Chemotherapy in Breast Cancer: A Prospective Bioimpedance Study
- ClinicalTrials.gov ID
- NCT07315880
- Acronym / sponsor ID
- FNH2025-2
- Conditions
- Lymphedema Arm
- Keywords
- breast neoplasm, lymphedema, neoadjuvant chemotherapy, breast cancer related lymphedema, extracellular fluid accumulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Florence Nightingale Hospital, IstanbulUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
At both visits, segmental bioimpedance spectroscopy using the L-Dex U400® device and upper extremity circumference measurements are performed following standardized procedures. For bioimpedance spectroscopy, two consecutive measurements are obtained and averaged to generate the L-Dex score. Arm circumferences are measured at 5-cm intervals along the upper limb, with three measurements averaged at each point. All assessments are conducted by the same trained clinician to ensure measurement consistency.
The standard neoadjuvant chemotherapy regimen consists of four cycles of intravenous doxorubicin (60 mg/m²) and cyclophosphamide (600 mg/m²) administered every 21 days, followed by weekly paclitaxel (80 mg/m²) for 12 weeks. Patients with HER2-positive disease receive trastuzumab and pertuzumab according to standard loading and maintenance dosing schedules concurrently with paclitaxel therapy.
The study evaluates changes in extracellular fluid status using bioimpedance spectroscopy and arm circumference measurements, and explores associations between these changes and selected patient- and disease-related characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Extravascular (Extracellular) Fluid of the Upper Extremity
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Background: PubMed 25940996Swaroop 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.
- Background: PubMed 9779722Semb 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.
- The Diagnosis and Treatment of Peripheral Lymphedema: 2023 Consensus Document of The International Society of LymphologyLink provided by the sponsor.
- Impact of adjuvant taxane-based chemotherapy on development of breast cancer-related lymphedema: results from a large prospective cohortLink provided by the sponsor.
- Evaluation of Long-Term Lymphedema Rate in Patients With Subclinical Lymphedema Diagnosed in the Preoperative Period via BioimpedanceLink provided by the sponsor.
- L-dex ratio in detecting breast cancer-related lymphedema: reliability, sensitivity, and specificityLink provided by the sponsor.
- Bioimpedance spectroscopy for breast cancer-related lymphedema assessment: clinical practice guidelinesLink provided by the sponsor.
- Lymphedema following taxane-based chemotherapy in women with early breast cancerLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. At this time, the plan for sharing individual participant data (IPD) has not been finalized. Decisions regarding data sharing will depend on future considerations, including participant privacy, ethical approvals, and institutional policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Erdoğan İyigün, Prof study chair
Bahçeşehir Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema Arm, run by Florence Nightingale Hospital, Istanbul at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Extravascular (Extracellular) Fluid of the Upper Extremity (time frame: Baseline (pre-NACT) to two weeks after completion of neoadjuvant chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07315880, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.