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

NCT07019740 | Completed

• 1 other identifier: MarmaraU.FTR.N.T.
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema, Breast Cancer

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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

  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 pain rating in the affected arm 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

• Comparison of primary measurements with tightness rating in the affected arm in patients with breast cancer related lymphedema

  Day 1

Study Arms (2)

CASE GROUP

BREAST CANCER RELATED LYPMHEDEMA

Other: CASE GROUP

CONTROL GROUP

HEALTHY GROUP

Other: CASE GROUP

Interventions

CASE GROUP OTHER

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

CASE GROUP; CONTROL GROUP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

BREAST CANCER RELATED LYMPHEDEMA

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Istanbul, 34890, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema

Interventions

Diagnosis-Related Groups

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prospective Payment System; Reimbursement Mechanisms; Insurance, Health, Reimbursement; Financing, Organized; Economics; Health Care Economics and Organizations

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 13, 2025
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)