CompletedNot Applicable

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

Turkey (Türkiye)60 participantsStarted 2025-01-25

Plain-language 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).

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Lymphedema volume difference and sympathetic skin response (SSR) parameters

Timeframe: Baseline and after 3 weeks of complex decongestive therapy

Trial details

NCT IDNCT07585253

SponsorGaziler Physical Medicine and Rehabilitation Education and Research Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-02-12

View on ClinicalTrials.gov More Breast Cancer-Related Lymphedema trials