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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07585253
Acronym
BCRL-SSR
Enrollment
60
Registered
2026-05-13
Start date
2025-01-25
Completion date
2026-02-12
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomic Dysfunction, Breast Cancer-Related Lymphedema, Postmastectomy Lymphedema

Keywords

Sympathetic Skin Response, Complex Decongestive Therapy, R-R Interval Variability, COMPASS-31, Breast Cancer, Rehabilitation, Lymphedema

Brief 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).

Detailed description

Breast cancer-related lymphedema is a chronic condition that develops following breast cancer treatment and is traditionally considered to result from impaired lymphatic drainage and fluid accumulation. Recent evidence suggests that autonomic nervous system dysfunction may also contribute to the pathophysiology of lymphedema. The aim of this prospective observational study was to evaluate sympathetic skin response (SSR), autonomic nervous system functions, and their relationship with clinical response to complex decongestive therapy (CDT) in patients with postmastectomy upper extremity lymphedema. Thirty female patients aged 18-65 years with unilateral upper extremity lymphedema after breast cancer treatment and thirty healthy female controls were included. All participants underwent electrophysiological autonomic nervous system evaluation using SSR and R-R interval variability measurements. In addition, autonomic symptoms were assessed using the Composite Autonomic Symptom Score-31 (COMPASS-31). Patients in the lymphedema group received a standardized CDT program for 3 weeks, 5 days per week, totaling 15 sessions. Clinical response to treatment was evaluated using changes in lymphedema volume measurements obtained before and after treatment. Secondary clinical assessments included quality of life evaluation with LYMQOL-Arm, upper extremity functional assessment with QuickDASH, pain severity assessment using the Numeric Rating Scale (NRS), and neuropathic pain evaluation using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS). The study aimed to determine whether autonomic dysfunction is present in breast cancer-related lymphedema and whether baseline SSR parameters are associated with clinical response to CDT.

Interventions

None listed

Sponsors

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Lymphedema volume difference and sympathetic skin response (SSR) parametersBaseline and after 3 weeks of complex decongestive therapyUpper 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

MeasureTime frameDescription
R-R interval variability (RRIV)Baseline and after 3 weeks of complex decongestive therapyCardiac autonomic function was evaluated using R-R interval variability measurements during resting and deep breathing conditions.
COMPASS-31 scoreBaseline and after 3 weeks of complex decongestive therapyAutonomic symptoms were evaluated using the Composite Autonomic Symptom Score-31 questionnaire.
LYMQOL-Arm scoreBaseline and after 3 weeks of complex decongestive therapyQuality of life related to upper extremity lymphedema was evaluated using the LYMQOL-Arm questionnaire.
QuickDASH scoreBaseline and after 3 weeks of complex decongestive therapyUpper extremity functional status was assessed using the QuickDASH questionnaire.
Numeric Rating Scale (NRS)Baseline and after 3 weeks of complex decongestive therapyPain severity was evaluated using the Numeric Rating Scale.
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)Baseline and after 3 weeks of complex decongestive therapyNeuropathic pain symptoms were evaluated using the LANSS questionnaire.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026