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Completed

NCT Number: NCT07585253

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Lymphedema volume difference and sympathetic skin response (SSR) parameters

    Time frame: Baseline and after 3 weeks of complex decongestive therapy

    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

  1. R-R interval variability (RRIV)

    Time frame: Baseline and after 3 weeks of complex decongestive therapy

    Cardiac autonomic function was evaluated using R-R interval variability measurements during resting and deep breathing conditions.

  2. COMPASS-31 score

    Time frame: Baseline and after 3 weeks of complex decongestive therapy

    Autonomic symptoms were evaluated using the Composite Autonomic Symptom Score-31 questionnaire.

  3. LYMQOL-Arm score

    Time frame: Baseline and after 3 weeks of complex decongestive therapy

    Quality of life related to upper extremity lymphedema was evaluated using the LYMQOL-Arm questionnaire.

  4. QuickDASH score

    Time frame: Baseline and after 3 weeks of complex decongestive therapy

    Upper extremity functional status was assessed using the QuickDASH questionnaire.

  5. Numeric Rating Scale (NRS)

    Time frame: Baseline and after 3 weeks of complex decongestive therapy

    Pain severity was evaluated using the Numeric Rating Scale.

  6. Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)

    Time frame: Baseline and after 3 weeks of complex decongestive therapy

    Neuropathic pain symptoms were evaluated using the LANSS questionnaire.

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Acronym: BCRL-SSR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 13, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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