Overview
The aim of this study is to evaluate the effectiveness of extracorporeal shock wave therapy (ESWT) combined with complete decongestive therapy (CDT) compared with CDT alone in patients with breast cancer-related lymphedema.
Female patients with unilateral Stage II upper-extremity lymphedema related to breast cancer will be included. Participants will receive either complete decongestive therapy alone or complete decongestive therapy combined with extracorporeal shock wave therapy.
Clinical outcomes will be evaluated before treatment, immediately after treatment, and at 1 and 3 months after treatment. Primary outcomes will include limb circumference difference, volumetric measurements, and ultrasonographic assessment of skin and subcutaneous tissue thickness. Secondary outcomes will include upper-extremity function, quality of life, and pain.
Description
Breast cancer-related lymphedema is a chronic condition characterized by impaired lymphatic drainage, accumulation of protein-rich interstitial fluid, chronic inflammation, and progressive tissue fibrosis. Complete decongestive therapy is currently considered the standard treatment for lymphedema. However, treatment response may be insufficient in some patients, and additional physical therapy modalities may be required.
Extracorporeal shock wave therapy is a mechanotherapy modality that generates high-amplitude mechanical acoustic waves. Previous studies suggest that low-energy ESWT may promote tissue regeneration, endothelial neoangiogenesis, modulation of inflammation, reduction of pain, prevention of soft-tissue fibrosis, and lymphangiogenesis.
The present study aims to investigate whether the addition of ESWT to complete decongestive therapy provides additional clinical benefits compared with complete decongestive therapy alone in patients with breast cancer-related Stage II lymphedema.
Unlike previous studies that have primarily evaluated short-term outcomes, participants in this study will also be assessed at 3 months after completion of treatment. In addition, only patients with a lymphedema duration of less than 4 years and Stage II disease will be included. Ultrasonographic assessment of skin and subcutaneous tissue thickness will also be performed to investigate the potential effects of ESWT on tissue fibrosis.
Eligibility
Inclusion Criteria:Female patients with unilateral upper-extremity lymphedema related to breast cancer.
At least 2 years have elapsed since the diagnosis of breast cancer, cancer treatment has been completed, and cure has been documented during oncology follow-up.
Stage II lymphedema according to the International Society of Lymphology classification.
Duration of lymphedema of less than 4 years.
Voluntary participation in the study. -
Exclusion Criteria: Poor general health status.
Open wounds, sensory deficits, or other conditions in the treatment area that may constitute a contraindication to treatment.
Active infection.
Presence of metastasis.
Bilateral breast cancer.
Bilateral lymphedema.
Use of anticoagulant therapy or presence of a coagulation disorder.
Cognitive impairment that may prevent completion of study assessment procedures.
Physical therapy, including electrotherapy or exercise therapy, ESWT, or regular use of nonsteroidal anti-inflammatory drugs within the previous 6 months.
Systemic inflammatory or autoimmune disorders such as rheumatoid arthritis or systemic lupus erythematosus.
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