Clinical Trial

Evaluation of Sympathetic Skin Response and Its Relationship With Clinical Response to Complex Decongestive Therapy in Patients With Postmastectomy Lymphedema

Study acronym: BCRL-SSR
Completed
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Summary
This prospective observational single-center study aimed to evaluate sympathetic skin response (SSR) in patients with postmastectomy upper extremity lymphedema and to investigate the relationship between SSR parameters and clinical response to complex decongestive therapy (CDT). Thirty female patients with breast cancer-related lymphedema and thirty healthy female controls were included in the study. All participants underwent autonomic nervous system assessment using SSR and R-R interval variability measurements and completed the Composite Autonomic Symptom Score-31 (COMPASS-31) questionnaire. Patients in the lymphedema group received a standardized 3-week CDT program consisting of 15 treatment sessions. Clinical response to treatment was evaluated by calculating changes in lymphedema volume before and after treatment. Quality of life, upper extremity function, pain severity, and neuropathic pain symptoms were assessed using LYMQOL-Arm, QuickDASH, Numeric Rating Scale (NRS), and Leeds Assessment of Neuropathic Symptoms and Signs (LANSS).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-05-07.
Trial Details
NCT Number NCT07585253
Lead Sponsor Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Conditions Breast Cancer-Related Lymphedema, Autonomic Dysfunction, Postmastectomy Lymphedema
Enrollment 60 participants
Start Date 2025-01-25
Primary Completion 2026-02-12 (estimated)
Study Completion 2026-02-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-22