Evaluatıon of sympathetıc Nervous System fındıngs and theır relatıonshıp wıth Symptoms ın patıents wıth Breast Cancer Related Lymphedema

Browse trials for

• Breast Neoplasms 12,543
• Lymphedema 560
• Breast Cancer Lymphedema 147

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 52 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Lead sponsor

Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.

Study population

Groups and cohorts

• CASE GROUP

  BREAST CANCER RELATED LYPMHEDEMA

  Other: CASE GROUP

• CONTROL GROUP

  HEALTHY GROUP

  Other: CASE GROUP

Interventions

• OtherCASE GROUP

  SYMPATHETIC SKIN RESPONSE, CUTANEOUS QUIET PERIOD AND COMPASS-31 QUESTIONNAIRE EVALUATED

Primary outcomes

1. 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.

   Time frame: Day 1

2. 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.

   Time frame: Day 1

3. 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.

   Time frame: Day 1

4. 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.

   Time frame: Day 1

5. 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.

   Time frame: Day 1

Secondary outcomes

1. 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.

   Time frame: Day 1

2. 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.

   Time frame: Day 1

3. 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.

   Time frame: Day 1

4. 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.

   Time frame: Day 1

5. 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.

   Time frame: Day 1

Individual participant data

Plan to share: No