Breast Cancer Related LymphedemaNCT07854262
EFFECT OF ESWT ON BREAST-CANCER RELATED LYMPHEDEMA
A study testing Complete Decongestive Therapy and Extracorporeal Shock Wave Therapy in people with Breast Cancer Related Lymphedema, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Related Lymphedema
- What is being tested?
- Complete Decongestive Therapy and Extracorporeal Shock Wave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2024to 14 Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
Ankara
ŞEBNEM ÖVER, MD, 05422477954, sebnemfahli@gmail.com
şebnem över, MD
About this study
Official title: EFFECTIVENESS OF EXTRACORPOREAL SHOCK-WAVE THERAPY(ESWT) IN PATIENTS WITH BREAST CANCER-RELATED LYMPHEDEMA
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.
Read the 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.
- Conditions
- Breast Cancer Related Lymphedema
- Being tested
- Complete Decongestive Therapy, Extracorporeal Shock Wave Therapy
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Decongestive TherapyOther
Also called CDT
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 TherapyDevice
Also called ESWT
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Complete Decongestive Therapy; Device: Extracorporeal Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Upper-extremity functional status will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire.
Measured: 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
Lymphedema-related quality of life will be assessed using the Lymphedema Quality of Life Questionnaire (LYMQOL).
Measured: 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
Upper-extremity pain experienced during the previous week will be evaluated using a Visual Analog Scale (VAS).
Measured: Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start20 Nov 2024
- Primary completion14 Oct 2026 (estimated)
- Study completion14 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Related LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şebnem Fahlioğulları, Ankara City Hospital Bilkent
- Investigators
- sibel ünsal delialioğlu, MD, Principal investigator, Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854262
- Sponsor's protocol ID
- E2-24-8553
- Status last verified
- Jul 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data (IPD) with other researchers. The study protocol does not include an IPD-sharing plan.