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
- Are there results?
- Not yet: the study is under way
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.
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- 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.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF EXTRACORPOREAL SHOCK-WAVE THERAPY(ESWT) IN PATIENTS WITH BREAST CANCER-RELATED LYMPHEDEMA
- ClinicalTrials.gov ID
- NCT07854262
- Acronym / sponsor ID
- E2-24-8553
- Conditions
- Breast Cancer Related Lymphedema
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 14 Oct 2026 (estimated)
- Study completion
- 14 Oct 2026 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Complete Decongestive Therapy | Active comparator | Other: Complete Decongestive TherapyParticipants 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. |
| Complete Decongestive Therapy Plus Extracorporeal Shock Wave Therapy | Experimental | Other: Complete Decongestive Therapy, Device: Extracorporeal Shock Wave TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete Decongestive TherapyAlso: CDTComplete 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 | Other | Complete Decongestive Therapy, Complete Decongestive Therapy Plus Extracorporeal Shock Wave Therapy |
| Extracorporeal Shock Wave TherapyAlso: ESWTRadial 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 | Device | Complete Decongestive Therapy Plus Extracorporeal Shock Wave Therapy |
Primary outcome
Change in Upper-Extremity Circumference Difference
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Change in Upper-Extremity Function Assessed by the QuickDASH
Time frame: 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
Time frame: 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
Time frame: Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
sibel ünsal delialioğlu, MD principal investigator
Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact şebnem över, MD (05422477954, sebnemfahli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Upper-Extremity Circumference Difference (time frame: Baseline, immediately after completion of the 3-week treatment, 1 month after treatment, and 3 months after treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.