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Evaluation of Sympathetic Skin Response and Its Relationship With Clinical Response to Complex Decongestive Therapy in Patients With Postmastectomy Lymphedema (BCRL-SSR)

20 maj 2026 uppdaterad av: Sehri Baris, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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).

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

Kontakter och platser

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Studieorter

Turkiet (Türkiye)
- Ankara
  - Ankara, Ankara, Turkiet (Türkiye), 06800
    - Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Vuxen
Äldre vuxen

Tar emot friska volontärer

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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:

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

Studieplan

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Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Lymphedema volume difference and sympathetic skin response (SSR) parameters Tidsram: 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.	Baseline and after 3 weeks of complex decongestive therapy

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
R-R interval variability (RRIV) Tidsram: 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.	Baseline and after 3 weeks of complex decongestive therapy
COMPASS-31 score Tidsram: Baseline and after 3 weeks of complex decongestive therapy	Autonomic symptoms were evaluated using the Composite Autonomic Symptom Score-31 questionnaire.	Baseline and after 3 weeks of complex decongestive therapy
LYMQOL-Arm score Tidsram: Baseline and after 3 weeks of complex decongestive therapy	Quality of life related to upper extremity lymphedema was evaluated using the LYMQOL-Arm questionnaire.	Baseline and after 3 weeks of complex decongestive therapy
QuickDASH score Tidsram: Baseline and after 3 weeks of complex decongestive therapy	Upper extremity functional status was assessed using the QuickDASH questionnaire.	Baseline and after 3 weeks of complex decongestive therapy
Numeric Rating Scale (NRS) Tidsram: Baseline and after 3 weeks of complex decongestive therapy	Pain severity was evaluated using the Numeric Rating Scale.	Baseline and after 3 weeks of complex decongestive therapy
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Tidsram: Baseline and after 3 weeks of complex decongestive therapy	Neuropathic pain symptoms were evaluated using the LANSS questionnaire.	Baseline and after 3 weeks of complex decongestive therapy

Samarbetspartners och utredare

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Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 januari 2025

Primärt slutförande (Faktisk)

12 februari 2026

Avslutad studie (Faktisk)

12 februari 2026

Studieregistreringsdatum

Först inskickad

7 maj 2026

Först inskickad som uppfyllde QC-kriterierna

7 maj 2026

Första postat (Faktisk)

13 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

BCRL-SSR-2026

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