Breast Cancer-Related LymphedemaBCRL-SSRNCT07585253
Evaluation of Sympathetic Skin Response and Its Relationship With Clinical Response to Complex Decongestive Therapy in Patients With Postmastectomy Lymphedema
An observational study of Breast Cancer-Related Lymphedema and Autonomic Dysfunction, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational single-center study aimed to evaluate sympathetic skin response (SSR) in patients with postmastectomy upper extremity lymphedema and to investigate the relationship between SSR parameters and clinical response to complex decongestive therapy (CDT). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer-Related Lymphedema, Autonomic Dysfunction, Postmastectomy Lymphedema
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2025to 12 Feb 2026
- How long will I take part?
- 3 Weeks
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consisted of female patients aged 18-65 years with unilateral postmastectomy upper extremity lymphedema following breast cancer treatment and age-matched healthy female volunteers. Patients had completed breast cancer treatment protocols and had ISL stage I-II lymphedema. Healthy controls had no history of breast cancer, lymphedema, neurological disease, metabolic disorder, or systemic condition affecting autonomic nervous system function.
Who may be able to join
- Female patients aged between 18 and 65 years
- Postmastectomy upper extremity lymphedema after breast cancer surgery
- Completion of breast cancer treatment protocols
- International Society of Lymphology (ISL) stage I-II lymphedema
Who cannot join
- Metastatic breast cancer
- Bilateral breast cancer history
- Bilateral upper extremity lymphedema
- Ongoing chemotherapy or radiotherapy
- Infection or allergic skin lesions on the upper extremities
- Medical conditions causing edema, including decompensated heart, lung, or renal failure
Show all 10Show fewer
- Peripheral nervous system disease or polyneuropathy
- Chronic endocrine, metabolic, neurological, or systemic diseases affecting autonomic nervous system function, including diabetes mellitus, hypo/hyperthyroidism, uremia, heart failure, cardiac arrhythmia, and uncontrolled hypertension
- Presence of a cardiac pacemaker
- Inability to tolerate electrical stimulation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
Ankara, Ankara, 06800
About this study
This prospective observational single-center study aimed to evaluate sympathetic skin response (SSR) in patients with postmastectomy upper extremity lymphedema and to investigate the relationship between SSR parameters and clinical response to complex decongestive therapy (CDT).
Thirty female patients with breast cancer-related lymphedema and thirty healthy female controls were included in the study. All participants underwent autonomic nervous system assessment using SSR and R-R interval variability measurements and completed the Composite Autonomic Symptom Score-31 (COMPASS-31) questionnaire.
Patients in the lymphedema group received a standardized 3-week CDT program consisting of 15 treatment sessions. Clinical response to treatment was evaluated by calculating changes in lymphedema volume before and after treatment. Quality of life, upper extremity function, pain severity, and neuropathic pain symptoms were assessed using LYMQOL-Arm, QuickDASH, Numeric Rating Scale (NRS), and Leeds Assessment of Neuropathic Symptoms and Signs (LANSS).
Read the detailed description
Breast cancer-related lymphedema is a chronic condition that develops following breast cancer treatment and is traditionally considered to result from impaired lymphatic drainage and fluid accumulation. Recent evidence suggests that autonomic nervous system dysfunction may also contribute to the pathophysiology of lymphedema.
The aim of this prospective observational study was to evaluate sympathetic skin response (SSR), autonomic nervous system functions, and their relationship with clinical response to complex decongestive therapy (CDT) in patients with postmastectomy upper extremity lymphedema.
Thirty female patients aged 18-65 years with unilateral upper extremity lymphedema after breast cancer treatment and thirty healthy female controls were included. All participants underwent electrophysiological autonomic nervous system evaluation using SSR and R-R interval variability measurements. In addition, autonomic symptoms were assessed using the Composite Autonomic Symptom Score-31 (COMPASS-31).
Patients in the lymphedema group received a standardized CDT program for 3 weeks, 5 days per week, totaling 15 sessions. Clinical response to treatment was evaluated using changes in lymphedema volume measurements obtained before and after treatment.
Secondary clinical assessments included quality of life evaluation with LYMQOL-Arm, upper extremity functional assessment with QuickDASH, pain severity assessment using the Numeric Rating Scale (NRS), and neuropathic pain evaluation using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS).
The study aimed to determine whether autonomic dysfunction is present in breast cancer-related lymphedema and whether baseline SSR parameters are associated with clinical response to CDT.
- Keywords
- Sympathetic Skin Response, Complex Decongestive Therapy, R-R Interval Variability, COMPASS-31, Breast Cancer, Rehabilitation, Lymphedema
- Medical subject headings
- Breast Cancer Lymphedema, Primary Dysautonomias, Breast Neoplasms, Lymphedema
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphedema volume difference and sympathetic skin response (SSR) parameters
Upper extremity lymphedema volume difference and sympathetic skin response (SSR) parameters were evaluated before and after complex decongestive therapy. Limb volume was calculated using circumferential measurements obtained at 4-cm intervals with the truncated cone formula. SSR recordings were obtained using surface electrodes and median nerve stimulation. Peak-to-peak amplitude and latency values were analyzed.
Measured: Baseline and after 3 weeks of complex decongestive therapy
Secondary outcomes (6)
R-R interval variability (RRIV)
Cardiac autonomic function was evaluated using R-R interval variability measurements during resting and deep breathing conditions.
Measured: Baseline and after 3 weeks of complex decongestive therapy
COMPASS-31 score
Autonomic symptoms were evaluated using the Composite Autonomic Symptom Score-31 questionnaire.
Measured: Baseline and after 3 weeks of complex decongestive therapy
LYMQOL-Arm score
Quality of life related to upper extremity lymphedema was evaluated using the LYMQOL-Arm questionnaire.
Measured: Baseline and after 3 weeks of complex decongestive therapy
QuickDASH score
Upper extremity functional status was assessed using the QuickDASH questionnaire.
Measured: Baseline and after 3 weeks of complex decongestive therapy
Numeric Rating Scale (NRS)
Pain severity was evaluated using the Numeric Rating Scale.
Measured: Baseline and after 3 weeks of complex decongestive therapy
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
Neuropathic pain symptoms were evaluated using the LANSS questionnaire.
Measured: Baseline and after 3 weeks of complex decongestive therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start25 Jan 2025
- Primary completion12 Feb 2026
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer-Related LymphedemaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sehri Baris, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585253
- Sponsor's protocol ID
- BCRL-SSR-2026
- Acronym
- BCRL-SSR
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sympathetic Skin Response and Its Relationship With Clinical Response to Complex Decongestive Therapy in Patients With Postmastectomy Lymphedema
- ClinicalTrials.gov ID
- NCT07585253
- Acronym / sponsor ID
- BCRL-SSR / BCRL-SSR-2026
- Keywords
- Sympathetic Skin Response, Complex Decongestive Therapy, R-R Interval Variability, COMPASS-31, Breast Cancer, Rehabilitation, Lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 13 May 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.
This prospective observational single-center study aimed to evaluate sympathetic skin response (SSR) in patients with postmastectomy upper extremity lymphedema and to investigate the relationship between SSR parameters and clinical response to complex decongestive therapy (CDT).
Thirty female patients with breast cancer-related lymphedema and thirty healthy female controls were included in the study. All participants underwent autonomic nervous system assessment using SSR and R-R interval variability measurements and completed the Composite Autonomic Symptom Score-31 (COMPASS-31) questionnaire.
Patients in the lymphedema group received a standardized 3-week CDT program consisting of 15 treatment sessions. Clinical response to treatment was evaluated by calculating changes in lymphedema volume before and after treatment. Quality of life, upper extremity function, pain severity, and neuropathic pain symptoms were assessed using LYMQOL-Arm, QuickDASH, Numeric Rating Scale (NRS), and Leeds Assessment of Neuropathic Symptoms and Signs (LANSS).
Detailed description
Breast cancer-related lymphedema is a chronic condition that develops following breast cancer treatment and is traditionally considered to result from impaired lymphatic drainage and fluid accumulation. Recent evidence suggests that autonomic nervous system dysfunction may also contribute to the pathophysiology of lymphedema.
The aim of this prospective observational study was to evaluate sympathetic skin response (SSR), autonomic nervous system functions, and their relationship with clinical response to complex decongestive therapy (CDT) in patients with postmastectomy upper extremity lymphedema.
Thirty female patients aged 18-65 years with unilateral upper extremity lymphedema after breast cancer treatment and thirty healthy female controls were included. All participants underwent electrophysiological autonomic nervous system evaluation using SSR and R-R interval variability measurements. In addition, autonomic symptoms were assessed using the Composite Autonomic Symptom Score-31 (COMPASS-31).
Patients in the lymphedema group received a standardized CDT program for 3 weeks, 5 days per week, totaling 15 sessions. Clinical response to treatment was evaluated using changes in lymphedema volume measurements obtained before and after treatment.
Secondary clinical assessments included quality of life evaluation with LYMQOL-Arm, upper extremity functional assessment with QuickDASH, pain severity assessment using the Numeric Rating Scale (NRS), and neuropathic pain evaluation using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS).
The study aimed to determine whether autonomic dysfunction is present in breast cancer-related lymphedema and whether baseline SSR parameters are associated with clinical response to CDT.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of female patients aged 18-65 years with unilateral postmastectomy upper extremity lymphedema following breast cancer treatment and age-matched healthy female volunteers. Patients had completed breast cancer treatment protocols and had ISL stage I-II lymphedema. Healthy controls had no history of breast cancer, lymphedema, neurological disease, metabolic disorder, or systemic condition affecting autonomic nervous system function.
Key inclusion criteria (4 listed)
- Female patients aged between 18 and 65 years
- Postmastectomy upper extremity lymphedema after breast cancer surgery
- Completion of breast cancer treatment protocols
- International Society of Lymphology (ISL) stage I-II lymphedema
Key exclusion criteria (10 listed)
- Metastatic breast cancer
- Bilateral breast cancer history
- Bilateral upper extremity lymphedema
- Ongoing chemotherapy or radiotherapy
- Infection or allergic skin lesions on the upper extremities
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
Lymphedema volume difference and sympathetic skin response (SSR) parameters
Time frame: Baseline and after 3 weeks of complex decongestive therapy
Upper extremity lymphedema volume difference and sympathetic skin response (SSR) parameters were evaluated before and after complex decongestive therapy. Limb volume was calculated using circumferential measurements obtained at 4-cm intervals with the truncated cone formula. SSR recordings were obtained using surface electrodes and median nerve stimulation. Peak-to-peak amplitude and latency values were analyzed.
6 secondary outcomes
R-R interval variability (RRIV)
Time frame: Baseline and after 3 weeks of complex decongestive therapy
COMPASS-31 score
Time frame: Baseline and after 3 weeks of complex decongestive therapy
LYMQOL-Arm score
Time frame: Baseline and after 3 weeks of complex decongestive therapy
QuickDASH score
Time frame: Baseline and after 3 weeks of complex decongestive therapy
Numeric Rating Scale (NRS)
Time frame: Baseline and after 3 weeks of complex decongestive therapy
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
Time frame: Baseline and after 3 weeks of complex decongestive therapy
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 22 May 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Breast Cancer-Related Lymphedema and Autonomic Dysfunction, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital 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 4 inclusion and 10 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 22 May 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?
Lymphedema volume difference and sympathetic skin response (SSR) parameters (time frame: Baseline and after 3 weeks of complex decongestive therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.