EFFECT OF ESWT ON BREAST-CANCER RELATED LYMPHEDEMA

NCT07854262 | Recruiting

• 1 other identifier: E2-24-8553
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Related Lymphedema

Outcome Measures

Primary Outcomes (3)

• Change in Upper-Extremity Circumference Difference

  Circumference measurements will be obtained from both the affected and unaffected upper extremities, and the difference between the two extremities will be recorded.

  Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment.

• Change in Upper-Extremity Volume

  Upper-extremity volume will be calculated from serial circumference measurements using the truncated cone formula.

  Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment.

• Change in Skin and Subcutaneous Tissue Thickness Assessed by Ultrasonography

  Skin and subcutaneous tissue thickness will be assessed ultrasonographically at the dorsum of the hand, forearm, and upper arm.

  Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment.

Secondary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (2)

Complete Decongestive Therapy

ACTIVE COMPARATOR

Participants in this group will receive Phase I complete decongestive therapy for three weeks. Treatment will consist of manual lymphatic drainage, multilayer short-stretch bandaging, and lymphedema exercises. Complete decongestive therapy will be administered five sessions per week for a total of 15 sessions.

Other: Complete Decongestive Therapy

Complete Decongestive Therapy Plus Extracorporeal Shock Wave Therapy

EXPERIMENTAL

Participants in this group will receive Phase I complete decongestive therapy together with extracorporeal shock wave therapy. Complete decongestive therapy will be administered five sessions per week for three weeks, for a total of 15 sessions. Extracorporeal shock wave therapy will be administered three sessions per week for three weeks.

Other: Complete Decongestive Therapy; Device: Extracorporeal Shock Wave Therapy

Interventions

Complete Decongestive Therapy OTHER

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

Also known as: CDT

Complete Decongestive Therapy; Complete Decongestive Therapy Plus Extracorporeal Shock Wave Therapy

Extracorporeal Shock Wave Therapy DEVICE

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

Also known as: ESWT

Complete Decongestive Therapy Plus Extracorporeal Shock Wave Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Cancer Lymphedema

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• sibel ünsal delialioğlu, MD

  Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

şebnem över, MD

CONTACT

05422477954; sebnemfahli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Resident Physician

Model Details: 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).

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: November 20, 2024
• Primary Completion (Estimated): October 14, 2026
• Study Completion (Estimated): October 14, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)