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Chemo may trigger early lymphedema signs, study finds

NCT ID NCT07315880

Knowledge-focused Sponsor: Florence Nightingale Hospital, Istanbul Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether chemotherapy before breast cancer surgery causes extra fluid buildup in the arm, an early sign of lymphedema. Researchers measured 111 women's arm fluid before and after chemo using a special device. The goal was to understand how often this happens and who might be at higher risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

111 people

The number who actually took part.

Started

Jan 2021

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer Breast Cancer Lymphedema breast neoplasm lymphedema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphedema arm

Contacts and locations

Locations

  • Istanbul Florence Nightingale Hospital, Breast Health Center

    Istanbul, Sisli, 34381, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.