Clinical trial NCT07019740: Evaluatıon of sympathetıc Nervous System fındıngs and theır relatıonshıp wıth Symptoms ın patıents wıth Breast Cancer Related Lymphedema
Official title: Evaluatıon of sympathetıc Nervous System fındıngs and theır relatıonshıp wıth Symptoms ın patıents wıth Breast Cancer Related Lymphedema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema, Breast Cancer
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: BREAST CANCER RELATED LYMPHEDEMA

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patient age group between 18-75 years
* To have been diagnosed with breast cancer-related lymphedema by imaging and/or clinical diagnostic methods

Exclusion Criteria:

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

Primary outcomes:
measure: SSR latency in affected and unaffected arms of patient with breast cancer related lymphedema
timeFrame: Day 1
measure: SSR amplitude in affected and unaffected arms of patients with breast cancer related lymphedema
timeFrame: Day 1
measure: CSP latency in affected and unaffected arms pf patients with breast cancer related lymphedema
timeFrame: Day 1
measure: CSP duration in affected and unaffected arms of patients with breast cancer related lymphedema
timeFrame: Day 1
measure: COMPASS-31 total score and subdomains in patients with breast cancer related lymphedema
timeFrame: Day 1
Secondary outcomes:
measure: Comparison of primary measurements with Lymphedema Life Impact Scale total score and subdomains in patients with breast cancer related lymphedema
timeFrame: Day 1
measure: Comparison of primary measurements with limb volume difference between arms in patients with breast cancer related lymphedema
timeFrame: Day 1
measure: Comparison of primary measurements with pain rating in the affected arm in patients with breast cancer related lymphedema
timeFrame: Day 1
measure: Comparison of primary measurements with heaviness rating in the affected arm in patients with breast cancer related lymphedema
timeFrame: Day 1
measure: Comparison of primary measurements with tightness rating in the affected arm in patients with breast cancer related lymphedema
timeFrame: Day 1
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
References: