Evaluatıon of sympathetıc Nervous System fındıngs and theır relatıonshıp wıth Symptoms ın patıents wıth Breast Cancer Related Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- CSP latency in affected and unaffected arms pf patients with breast cancer related lymphedema
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient age group between 18-75 years
- •To have been diagnosed with breast cancer-related lymphedema by imaging and/or clinical diagnostic methods
排除标准
- •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
结局指标
主要结局
CSP latency in affected and unaffected arms pf patients with breast cancer related lymphedema
时间窗: 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.
COMPASS-31 total score and subdomains in patients with breast cancer related lymphedema
时间窗: 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.
SSR latency in affected and unaffected arms of patient with breast cancer related lymphedema
时间窗: 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.
CSP duration in affected and unaffected arms of patients with breast cancer related lymphedema
时间窗: 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.
SSR amplitude in affected and unaffected arms of patients with breast cancer related lymphedema
时间窗: 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.
次要结局
- Comparison of primary measurements with Lymphedema Life Impact Scale total score and subdomains in patients with breast cancer related lymphedema(Day 1)
- Comparison of primary measurements with pain rating in the affected arm in patients with breast cancer related lymphedema(Day 1)
- Comparison of primary measurements with tightness rating in the affected arm in patients with breast cancer related lymphedema(Day 1)
- Comparison of primary measurements with limb volume difference between arms in patients with breast cancer related lymphedema(Day 1)
- Comparison of primary measurements with heaviness rating in the affected arm in patients with breast cancer related lymphedema(Day 1)