Clinical trial · Observational
Evaluation of Sympathetic Skin Response and Its Relationship With Clinical Response to Complex Decongestive Therapy in Patients With Postmastectomy Lymphedema
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autonomic Dysfunction | — | UNRESOLVED | — |
| Breast Cancer-Related Lymphedema | — | UNRESOLVED | — |
| Postmastectomy Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Lymphedema volume difference and sympathetic skin response (SSR) parameters
- timeFrame
- Baseline and after 3 weeks of complex decongestive therapy
- description
- Upper extremity lymphedema volume difference and sympathetic skin response (SSR) parameters were evaluated before and after complex decongestive therapy. Limb volume was calculated using circumferential measurements obtained at 4-cm intervals with the truncated cone formula. SSR recordings were obtained using surface electrodes and median nerve stimulation. Peak-to-peak amplitude and latency values were analyzed.
Secondary outcomes (6)
- measure
- R-R interval variability (RRIV)
- timeFrame
- Baseline and after 3 weeks of complex decongestive therapy
- description
- Cardiac autonomic function was evaluated using R-R interval variability measurements during resting and deep breathing conditions.
- measure
- COMPASS-31 score
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Healthy Control Inclusion Criteria: * Female volunteers aged between 18 and 65 years * No history of breast cancer or lymphedema * No neurological, metabolic, or systemic disease affecting autonomic nervous system function Healthy Control Exclusion Criteria: * History of breast cancer or lymphedema * Polyneuropathy * Diabetes mellitus * Hypothyroidism * Neurological disease * Systemic diseases affecting autonomic nervous system function Patient group; Inclusion Criteria: Inclusion Criteria: * Female patients aged between 18 and 65 years * Postmastectomy upper extremity lymphedema after breast cancer surgery * Completion of breast cancer treatment protocols * International Society of Lymphology (ISL) stage I-II lymphedema Exclusion Criteria: * Metastatic breast cancer * Bilateral breast cancer history * Bilateral upper extremity lymphedema * Ongoing chemotherapy or radiotherapy * Infection or allergic skin lesions on the upper extremities * Medical conditions causing edema, including decompensated heart, lung, or renal failure * Peripheral nervous system disease or polyneuropathy * Chronic endocrine, metabolic, neurological, or systemic diseases affecting autonomic nervous system function, including diabetes mellitus, hypo/hyperthyroidism, uremia, heart failure, cardiac arrhythmia, and uncontrolled hypertension * Presence of a cardiac pacemaker * Inability to tolerate electrical stimulation
References
Publications (0)
Data not yet available