EFFECT OF ESWT ON BREAST-CANCER RELATED LYMPHEDEMA

Condition(s) studied

Investigational drug(s) / intervention(s)

Complete Decongestive Therapy: 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

Extracorporeal 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

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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