Lymphedema, Breast CancerNCT07019740
Evaluatıon of sympathetıc Nervous System fındıngs and theır relatıonshıp wıth Symptoms ın patıents wıth Breast Cancer Related Lymphedema
An observational study of Lymphedema, Breast Cancer, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the sympathetic nervous system, small fiber functions and autonomic symptoms in patients with breast cancer related lymphedema and to investigate the relationship between these findings and patients' symptoms. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lymphedema, Breast Cancer
- What is being tested?
- CASE GROUP
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 1 Dec 2024
- How long will I take part?
- 1 Day
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: BREAST CANCER RELATED LYMPHEDEMA
Who may be able to join
- Patient age group between 18-75 years
- To have been diagnosed with breast cancer-related lymphedema by imaging and/or clinical diagnostic methods
Who cannot join
- History of upper extremity lymphedema due to causes other than breast cancer
- Lymphedema in other body parts
- Diagnosis of polyneuropathy or entrapment neuropathy in the upper extremity
- Presence of active infection at the assessment site
- Presence of congenital or acquired malformations at the evaluation site
- Those with any medical condition that may cause edema, such as severe heart or kidney failure
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to evaluate the sympathetic nervous system, small fiber functions and autonomic symptoms in patients with breast cancer related lymphedema and to investigate the relationship between these findings and patients' symptoms.
Read the detailed description
This observational cross-sectional study aims to evaluate sympathetic nervous system activity, small fiber function, and autonomic symptoms in patients with breast cancer related lymphedema.
Electrophysiological parameters, including Sympathetic Skin Response (SSR) and Cutaneous Silent Period (CSP), will be recorded from both the affected and unaffected limbs using standardized neurophysiological techniques. Additionally, autonomic symptoms will be assessed using the Composite Autonomic Symptom Score 31 (COMPASS-31), and the impact of lymphedema on daily life will be evaluated with the Lymphedema Life Impact Scale (LLIS).
The study hypothesizes that sympathetic dysfunction and small fiber involvement may contribute to the pathophysiology of lymphedema and correlate with subjective symptoms such as pain, heaviness, and tightness.
Findings from this study are expected to provide insights into the potential role of the autonomic nervous system in breast cancer-related lymphedema and may support future consideration of sympathetic nervous system-targeted treatments.
- Conditions
- Lymphedema, Breast Cancer
- Being tested
- CASE GROUP
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CASE GROUPOther
SYMPATHETIC SKIN RESPONSE, CUTANEOUS QUIET PERIOD AND COMPASS-31 QUESTIONNAIRE EVALUATED
| Study group | Role | What they receive |
|---|---|---|
| CASE GROUP | BREAST CANCER RELATED LYPMHEDEMA Receives: Other: CASE GROUP | |
| CONTROL GROUP | HEALTHY GROUP Receives: Other: CASE GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
SSR latency in affected and unaffected arms of patient with breast cancer related lymphedema
Sympathetic skin response (SSR) latency will be recorded bilaterally using standard surface electrodes placed on the palm and dorsum of the hand. Electrical stimulation will be applied to the median nerve at the wrist with parameters of 20-30 mA and 0.2 ms pulse duration. Latency is defined as the time between stimulus and onset of the first deflection in the recording and will be expressed in milliseconds.
Measured: Day 1
SSR amplitude in affected and unaffected arms of patients with breast cancer related lymphedema
SSR amplitude will be recorded bilaterally using surface electrodes. Amplitude is measured as the peak-to-peak voltage of the waveform following stimulation of the median nerve at the wrist using standard stimulation parameters. Recordings will be performed with a standard EMG device and values will be reported in microvolts.
Measured: Day 1
CSP latency in affected and unaffected arms pf patients with breast cancer related lymphedema
Cutaneous Silent Period (CSP) latency will be measured by applying painful electrical stimulation to the index finger and recording EMG activity from the abductor pollicis brevis muscle. Latency is defined as the time between the stimulus and the onset of EMG suppression. Standard protocols for CSP measurement will be followed.
Measured: Day 1
CSP duration in affected and unaffected arms of patients with breast cancer related lymphedema
CSP duration will be calculated as the time between the onset of EMG suppression and the return to baseline voluntary EMG activity following electrical stimulation. Recordings will be made using an EMG system and reported in milliseconds.
Measured: Day 1
COMPASS-31 total score and subdomains in patients with breast cancer related lymphedema
The Composite Autonomic Symptom Score 31 (COMPASS-31) questionnaire will be used to evaluate autonomic symptoms. It includes domains such as orthostatic intolerance, secretomotor, vasomotor, gastrointestinal, bladder, and pupillomotor symptoms. The total score ranges from 0 to 100, where higher scores indicate more severe autonomic dysfunction.
Measured: Day 1
Secondary outcomes (5)
Comparison of primary measurements with Lymphedema Life Impact Scale total score and subdomains in patients with breast cancer related lymphedema
The Lymphedema Life Impact Scale (LLIS) will be used to evaluate the impact of lymphedema on function, symptoms, and emotional well-being. Each item on the LLIS is scored using a 5-point likert scale, ranging from 1 to 5. Higher LLIS scores indicated greater disability and reduced quality of life in patients with breast cancer related lymphedemaParticipants will complete the questionnaire and scores will be correlated with electrophysiological and autonomic findings.
Measured: Day 1
Comparison of primary measurements with limb volume difference between arms in patients with breast cancer related lymphedema
The volume of the affected and unaffected limbs will be calculated using a circumferential measurement method. Measurements will be taken at regular intervals along the limb, and limb volume will be estimated using the truncated cone formula:
V = Σ [π × h × (C₁² + C₁×C₂ + C₂²) / 12π] where C₁ and C₂ are the circumferences at two adjacent levels and h is the distance between them. This approach allows for volume estimation without the use of water displacement. The interlimb volume difference (affected minus unaffected arm) will be calculated in milliliters and compared with primary outcome measures.
Measured: Day 1
Comparison of primary measurements with pain rating in the affected arm in patients with breast cancer related lymphedema
Patients will rate their pain in the affected arm using a numeric rating scale from 0 (no pain) to 10 (worst pain imaginable). Scores will be compared with primary outcome measures.
Measured: Day 1
Comparison of primary measurements with heaviness rating in the affected arm in patients with breast cancer related lymphedema
Patients will report their perception of heaviness in the affected arm using a numeric scale ranging from 0 to 10. These scores will be compared with SSR, CSP and Compass 31 results.
Measured: Day 1
Comparison of primary measurements with tightness rating in the affected arm in patients with breast cancer related lymphedema
Patients will evaluate the tightness sensation in the affected limb on a 0-10 numeric rating scale. Data will be analyzed in association with SSR, CSP and Compass 31 results.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Oct 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema, Breast CancerStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 52 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019740
- Sponsor's protocol ID
- MarmaraU.FTR.N.T.
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 13 Jun 2025
- 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 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluatıon of sympathetıc Nervous System fındıngs and theır relatıonshıp wıth Symptoms ın patıents wıth Breast Cancer Related Lymphedema
- ClinicalTrials.gov ID
- NCT07019740
- Acronym / sponsor ID
- MarmaraU.FTR.N.T.
- Conditions
- Lymphedema, Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 13 Jun 2025 (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 aim of this study was to evaluate the sympathetic nervous system, small fiber functions and autonomic symptoms in patients with breast cancer related lymphedema and to investigate the relationship between these findings and patients' symptoms.
Detailed description
This observational cross-sectional study aims to evaluate sympathetic nervous system activity, small fiber function, and autonomic symptoms in patients with breast cancer related lymphedema.
Electrophysiological parameters, including Sympathetic Skin Response (SSR) and Cutaneous Silent Period (CSP), will be recorded from both the affected and unaffected limbs using standardized neurophysiological techniques. Additionally, autonomic symptoms will be assessed using the Composite Autonomic Symptom Score 31 (COMPASS-31), and the impact of lymphedema on daily life will be evaluated with the Lymphedema Life Impact Scale (LLIS).
The study hypothesizes that sympathetic dysfunction and small fiber involvement may contribute to the pathophysiology of lymphedema and correlate with subjective symptoms such as pain, heaviness, and tightness.
Findings from this study are expected to provide insights into the potential role of the autonomic nervous system in breast cancer-related lymphedema and may support future consideration of sympathetic nervous system-targeted treatments.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CASE GROUP | – | Other: CASE GROUPBREAST CANCER RELATED LYPMHEDEMA |
| CONTROL GROUP | – | Other: CASE GROUPHEALTHY GROUP |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- BREAST CANCER RELATED LYMPHEDEMA
Key inclusion criteria (2 listed)
- Patient age group between 18-75 years
- To have been diagnosed with breast cancer-related lymphedema by imaging and/or clinical diagnostic methods
Key exclusion criteria (6 listed)
- History of upper extremity lymphedema due to causes other than breast cancer
- Lymphedema in other body parts
- Diagnosis of polyneuropathy or entrapment neuropathy in the upper extremity
- Presence of active infection at the assessment site
- Presence of congenital or acquired malformations at the evaluation site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CASE GROUPSYMPATHETIC SKIN RESPONSE, CUTANEOUS QUIET PERIOD AND COMPASS-31 QUESTIONNAIRE EVALUATED | Other | CASE GROUP, CONTROL GROUP |
Primary outcome
SSR latency in affected and unaffected arms of patient with breast cancer related lymphedema
Time frame: Day 1
Sympathetic skin response (SSR) latency will be recorded bilaterally using standard surface electrodes placed on the palm and dorsum of the hand. Electrical stimulation will be applied to the median nerve at the wrist with parameters of 20-30 mA and 0.2 ms pulse duration. Latency is defined as the time between stimulus and onset of the first deflection in the recording and will be expressed in milliseconds.
SSR amplitude in affected and unaffected arms of patients with breast cancer related lymphedema
Time frame: Day 1
SSR amplitude will be recorded bilaterally using surface electrodes. Amplitude is measured as the peak-to-peak voltage of the waveform following stimulation of the median nerve at the wrist using standard stimulation parameters. Recordings will be performed with a standard EMG device and values will be reported in microvolts.
CSP latency in affected and unaffected arms pf patients with breast cancer related lymphedema
Time frame: Day 1
Cutaneous Silent Period (CSP) latency will be measured by applying painful electrical stimulation to the index finger and recording EMG activity from the abductor pollicis brevis muscle. Latency is defined as the time between the stimulus and the onset of EMG suppression. Standard protocols for CSP measurement will be followed.
CSP duration in affected and unaffected arms of patients with breast cancer related lymphedema
Time frame: Day 1
CSP duration will be calculated as the time between the onset of EMG suppression and the return to baseline voluntary EMG activity following electrical stimulation. Recordings will be made using an EMG system and reported in milliseconds.
COMPASS-31 total score and subdomains in patients with breast cancer related lymphedema
Time frame: Day 1
The Composite Autonomic Symptom Score 31 (COMPASS-31) questionnaire will be used to evaluate autonomic symptoms. It includes domains such as orthostatic intolerance, secretomotor, vasomotor, gastrointestinal, bladder, and pupillomotor symptoms. The total score ranges from 0 to 100, where higher scores indicate more severe autonomic dysfunction.
5 secondary outcomes
Comparison of primary measurements with Lymphedema Life Impact Scale total score and subdomains in patients with breast cancer related lymphedema
Time frame: Day 1
Comparison of primary measurements with limb volume difference between arms in patients with breast cancer related lymphedema
Time frame: Day 1
Comparison of primary measurements with pain rating in the affected arm in patients with breast cancer related lymphedema
Time frame: Day 1
Comparison of primary measurements with heaviness rating in the affected arm in patients with breast cancer related lymphedema
Time frame: Day 1
Comparison of primary measurements with tightness rating in the affected arm in patients with breast cancer related lymphedema
Time frame: Day 1
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 13 Jun 2025.
- 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 Lymphedema, Breast Cancer, run by Marmara University 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 2 inclusion and 6 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 13 Jun 2025. 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?
SSR latency in affected and unaffected arms of patient with breast cancer related lymphedema (time frame: Day 1). The study lists 5 primary outcomes in all. 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 13 Jun 2025.