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

NCT07585253 | Completed

• 1 other identifier: BCRL-SSR-2026
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer-Related Lymphedema; Autonomic Dysfunction; Postmastectomy Lymphedema

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Lymphedema volume difference and sympathetic skin response (SSR) parameters

  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.

  Baseline and after 3 weeks of complex decongestive therapy

Secondary Outcomes (6)

• R-R interval variability (RRIV)

  Baseline and after 3 weeks of complex decongestive therapy

• COMPASS-31 score

  Baseline and after 3 weeks of complex decongestive therapy

• LYMQOL-Arm score

  Baseline and after 3 weeks of complex decongestive therapy

• QuickDASH score

  Baseline and after 3 weeks of complex decongestive therapy

• Numeric Rating Scale (NRS)

  Baseline and after 3 weeks of complex decongestive therapy

Eligibility Criteria

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

Study Population

The study population consisted of female patients aged 18-65 years with unilateral postmastectomy upper extremity lymphedema following breast cancer treatment and age-matched healthy female volunteers. Patients had completed breast cancer treatment protocols and had ISL stage I-II lymphedema. Healthy controls had no history of breast cancer, lymphedema, neurological disease, metabolic disorder, or systemic condition affecting autonomic nervous system function.

You may qualify if:

• 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

You may not qualify if:

• History of breast cancer or lymphedema
• Polyneuropathy
• Diabetes mellitus
• Hypothyroidism
• Neurological disease
• Systemic diseases affecting autonomic nervous system function
• Patient group;
• 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
• Metastatic breast cancer
• Bilateral breast cancer history
• Bilateral upper extremity lymphedema
• Ongoing chemotherapy or radiotherapy

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Ankara, Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema; Primary Dysautonomias; Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician in Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start: January 25, 2025
• Primary Completion: February 12, 2026
• Study Completion: February 12, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)