Breast Cancer Related Lymphedema
Conditions
Brief summary
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.
Detailed 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.
Interventions
Complete decongestive therapy will consist of manual lymphatic drainage performed by an experienced physiotherapist according to the Vodder technique for 45-60 minutes, followed by multilayer short-stretch bandaging and lymphedema exercises performed under the supervision of the physiotherapist. Treatment will be administered five sessions per week for a total of 15 sessions. Arm Cross-Reference: Complete Decongestive Therapy Complete Decongestive Therapy Plus Extracorporeal Shock Wave Therapy
DEVICEExtracorporeal Shock Wave Therapy
Radial extracorporeal shock wave therapy will be administered using a pressure of 2 bar, a frequency of 4 Hz, and a total of 2,500 shocks per session. The shocks will be distributed as follows: Axillary region: 750 shocks Upper arm: 500 shocks Cubital region: 250 shocks Forearm: 500 shocks Dorsum of the hand: 500 shocks ESWT will be administered three sessions per week for three weeks. Arm Cross-Reference: Complete Decongestive Therapy Plus Extracorporeal Shock Wave Therapy
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants will be assigned to one of two parallel treatment groups: complete decongestive therapy (CDT) alone or CDT combined with extracorporeal shock wave therapy (ESWT).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Upper-Extremity Circumference Difference | Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment. | Circumference measurements will be obtained from both the affected and unaffected upper extremities, and the difference between the two extremities will be recorded. |
| Change in Upper-Extremity Volume | Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment. | Upper-extremity volume will be calculated from serial circumference measurements using the truncated cone formula. |
| Change in Skin and Subcutaneous Tissue Thickness Assessed by Ultrasonography | Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment. | Skin and subcutaneous tissue thickness will be assessed ultrasonographically at the dorsum of the hand, forearm, and upper arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Upper-Extremity Function Assessed by the QuickDASH | Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment. | Upper-extremity functional status will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. |
| Change in Lymphedema-Related Quality of Life Assessed by LYMQOL | Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment. | Lymphedema-related quality of life will be assessed using the Lymphedema Quality of Life Questionnaire (LYMQOL). |
| Change in Upper-Extremity Pain Assessed by Visual Analog Scale | Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment. | Upper-extremity pain experienced during the previous week will be evaluated using a Visual Analog Scale (VAS). |
Countries
Turkey (Türkiye)
Contacts
CONTACTşebnem över, MD
PRINCIPAL_INVESTIGATORsibel ünsal delialioğlu, MD
Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
Outcome results
None listed