Breast Cancer LymphedemaNCT07862296
Radial Shock Wave Treatment Alongside Decongestive Care for Arm Swelling After Breast Cancer
A study testing Complex decongestive therapy and Radial extracorporeal shock wave therapy in people with Breast Cancer Lymphedema, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Arm swelling can persist after breast cancer treatment and may interfere with comfort, movement, and everyday activities. Decongestive care combines several approaches to manage this swelling. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Lymphedema
- What is being tested?
- Complex decongestive therapy and Radial extracorporeal shock wave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2022to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age 18 years or older.
- A history of breast cancer with unilateral upper-limb lymphedema established by clinical evaluation and lymphoscintigraphy.
- Stage 2 or stage 3 lymphedema according to the International Society of Lymphology classification.
- Availability of electronic medical records containing sex, age, weight, height, body mass index, occupation, comorbid conditions, medication use, and chemotherapy and radiotherapy history.
- Written informed consent to participate.
Who cannot join
- Active malignancy.
- Ongoing chemotherapy or radiotherapy.
- Clinical evidence of infection in the affected upper limb.
- Advanced cardiac or renal failure.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University Faculty of Medicine Hospital
Konya, Konya, 42250
About this study
Official title: Evaluation of the Effectiveness of Complex Decongestive Therapy and Extracorporeal Shock Wave Therapy in Patients With Lymphedema
Arm swelling can persist after breast cancer treatment and may interfere with comfort, movement, and everyday activities. Decongestive care combines several approaches to manage this swelling. This study examined whether adding radial shock wave treatment changed short-term outcomes compared with decongestive care alone.
Twenty-one adults with stage 2 or stage 3 lymphedema affecting one arm were assigned to two treatment groups. Both groups were allocated to a four-week decongestive program. The combined-treatment schedule also included twelve shock wave sessions. Assessments before and after treatment covered arm size, the thickness of the skin and the tissue beneath it, pain, difficulty using the arm, lymphedema-related quality of life, and shoulder and wrist movement. A physician who did not know the treatment assignment performed the physical and ultrasound measurements.
Read the detailed description
This single-center study evaluated a noninvasive addition to intensive rehabilitation for unilateral upper-limb lymphedema following breast cancer treatment. It was conducted at the Physical Medicine and Rehabilitation Clinic of Selcuk University Faculty of Medicine Hospital in Konya, Türkiye.
The comparison was designed to examine the contribution of radial shock wave treatment separately from the decongestive program received by both groups. Overall limb measurements and regional ultrasound assessments were used to examine different aspects of the response to treatment. Questionnaires and joint measurements provided complementary information about symptoms, everyday arm use, and mobility.
The assessment schedule included examinations before treatment and at the end of the four-week course. Circumference measurements were also obtained weekly during the intervention period. The same physician performed the objective assessments without knowledge of group assignment. Participants and the personnel providing treatment were aware of the assigned intervention.
The Selcuk University Faculty of Medicine Local Ethics Committee approved the study on October 4, 2022, under decision number 2022/410. Each participant provided written consent. This record describes a study that had already been completed before its initial submission to ClinicalTrials.gov.
- Conditions
- Breast Cancer Lymphedema
- Being tested
- Complex decongestive therapy, Radial extracorporeal shock wave therapy
- Keywords
- Upper-limb lymphedema, Radial extracorporeal shock wave therapy, Complex decongestive therapy, Ultrasonography, Cancer rehabilitation, Arm function
- 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.
Complex decongestive therapyOther
The planned course comprised four weeks of treatment on five days per week. Components included manual lymphatic drainage, multilayer short-stretch bandaging, skin care, and therapeutic exercise. Exercise activities addressed breathing, posture, shoulder-girdle movement, gentle stretching, and low-intensity active movement of the upper limb and fingers. Movements were performed slowly within a pain-free range while the compression bandages were in place.
Radial extracorporeal shock wave therapyDevice
An Intelect RPW Lite system (Chattanooga) was used to deliver radial pressure pulses with the participant lying supine. The scheduled regimen consisted of three sessions per week for four weeks. Each session used a pressure setting of 2 bar and a frequency of 4 Hz, with 2,500 pulses in total. Of these, 750 were directed to the axillary region and 250 to the cubital region; the remaining 1,500 were distributed across the arm, forearm, and hand.
| Study group | Role | What they receive |
|---|---|---|
| Decongestive care with radial shock wave therapy | Experimental | Participants were allocated to a four-week course of complex decongestive therapy with additional radial extracorporeal shock wave treatment. Decongestive sessions were scheduled on five days each week, and shock wave sessions on three days each week. Receives: Other: Complex decongestive therapy; Device: Radial extracorporeal shock wave therapy |
| Decongestive care alone | Active comparator | Participants were allocated to the same four-week complex decongestive program, without shock wave treatment. The planned schedule consisted of five treatment days per week. Receives: Other: Complex decongestive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in calculated affected upper-limb volume
Volume of the affected upper limb was estimated from circumference measurements using the truncated-cone method and expressed in liters. The week-4 volume was subtracted from the pretreatment volume. A positive value indicates a reduction in calculated limb volume.
Measured: Before the first treatment session and at the end of the four-week treatment course.
Secondary outcomes (16)
Reduction in arm circumference 10 cm above the cubital fossa
Circumference of the affected arm was measured in centimeters at a level 10 cm proximal to the cubital fossa. The reduction was calculated as the pretreatment measurement minus the week-4 measurement. Positive values represent a smaller circumference after treatment.
Measured: Before the first treatment session and at the end of the four-week treatment course.
Reduction in forearm circumference 10 cm below the cubital fossa
Circumference of the affected forearm was recorded in centimeters at a level 10 cm distal to the cubital fossa. The week-4 measurement was subtracted from the pretreatment measurement. Positive values represent a decrease in circumference.
Measured: Before the first treatment session and at the end of the four-week treatment course.
Reduction in skin thickness at 10 cm proximal to the cubital fossa
The thickness of the skin in the affected upper limb was measured 10 cm proximal to the cubital fossa by ultrasound using a linear-array transducer. Values were recorded in millimeters by the masked physician. Reduction was calculated as pretreatment thickness minus week-4 thickness; a positive value denotes thinning of the measured layer.
Measured: Before the first treatment session and at the end of the four-week treatment course.
Reduction in skin thickness at the cubital fossa
The thickness of the skin in the affected upper limb was measured at the cubital fossa by ultrasound using a linear-array transducer. Values were recorded in millimeters by the masked physician. Reduction was calculated as pretreatment thickness minus week-4 thickness; a positive value denotes thinning of the measured layer.
Measured: Before the first treatment session and at the end of the four-week treatment course.
Reduction in skin thickness at 10 cm distal to the cubital fossa
The thickness of the skin in the affected upper limb was measured 10 cm distal to the cubital fossa by ultrasound using a linear-array transducer. Values were recorded in millimeters by the masked physician. Reduction was calculated as pretreatment thickness minus week-4 thickness; a positive value denotes thinning of the measured layer.
Measured: Before the first treatment session and at the end of the four-week treatment course.
Reduction in subcutaneous tissue thickness at 10 cm proximal to the cubital fossa
The thickness of the subcutaneous tissue in the affected upper limb was measured 10 cm proximal to the cubital fossa by ultrasound using a linear-array transducer. Values were recorded in millimeters by the masked physician. Reduction was calculated as pretreatment thickness minus week-4 thickness; a positive value denotes thinning of the measured layer.
Measured: Before the first treatment session and at the end of the four-week treatment course.
Reduction in subcutaneous tissue thickness at the cubital fossa
The thickness of the subcutaneous tissue in the affected upper limb was measured at the cubital fossa by ultrasound using a linear-array transducer. Values were recorded in millimeters by the masked physician. Reduction was calculated as pretreatment thickness minus week-4 thickness; a positive value denotes thinning of the measured layer.
Measured: Before the first treatment session and at the end of the four-week treatment course.
Reduction in subcutaneous tissue thickness at 10 cm distal to the cubital fossa
The thickness of the subcutaneous tissue in the affected upper limb was measured 10 cm distal to the cubital fossa by ultrasound using a linear-array transducer. Values were recorded in millimeters by the masked physician. Reduction was calculated as pretreatment thickness minus week-4 thickness; a positive value denotes thinning of the measured layer.
Measured: Before the first treatment session and at the end of the four-week treatment course.
Reduction in the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score
The Turkish QuickDASH questionnaire was used to assess upper-limb symptoms and activity limitations. This 11-item instrument produces a score from 0 to 100, with higher values indicating greater disability. The reduction was calculated as the baseline score minus the week-4 score; a positive value indicates improvement.
Measured: Before the first treatment session and at the end of the four-week treatment course.
Reduction in upper-limb pain on the Visual Analog Scale
Participants rated pain in the affected upper limb using a Visual Analog Scale scored from 0, indicating no pain, to 10, indicating the most severe pain. Pain reduction was calculated by subtracting the week-4 score from the pretreatment score. Positive values indicate lower pain after treatment.
Measured: Before the first treatment session and at the end of the four-week treatment course.
Reduction in the Lymphedema Quality of Life Questionnaire-Arm function domain score
The function domain of the Turkish Lymphedema Quality of Life Questionnaire-Arm assessed limitations in daily activities attributable to arm lymphedema. Domain scores range from 1 to 4, with higher scores indicating greater impairment. The baseline domain score minus the week-4 domain score was calculated; positive values indicate improvement.
Measured: Before the first treatment session and at the end of the four-week treatment course.
Reduction in the Lymphedema Quality of Life Questionnaire-Arm appearance domain score
The appearance domain of the Turkish Lymphedema Quality of Life Questionnaire-Arm assessed the perceived effect of arm lymphedema on appearance. Domain scores range from 1 to 4, with higher scores indicating greater impairment. The baseline domain score minus the week-4 domain score was calculated; positive values indicate improvement.
Measured: Before the first treatment session and at the end of the four-week treatment course.
Reduction in the Lymphedema Quality of Life Questionnaire-Arm symptoms domain score
The symptoms domain of the Turkish Lymphedema Quality of Life Questionnaire-Arm assessed symptoms associated with arm lymphedema. Domain scores range from 1 to 4, with higher scores indicating greater impairment. The baseline domain score minus the week-4 domain score was calculated; positive values indicate improvement.
Measured: Before the first treatment session and at the end of the four-week treatment course.
Reduction in the Lymphedema Quality of Life Questionnaire-Arm mood domain score
The mood domain of the Turkish Lymphedema Quality of Life Questionnaire-Arm assessed the emotional impact of arm lymphedema. Domain scores range from 1 to 4, with higher scores indicating greater impairment. The baseline domain score minus the week-4 domain score was calculated; positive values indicate improvement.
Measured: Before the first treatment session and at the end of the four-week treatment course.
Increase in active shoulder flexion, abduction, adduction, extension, external rotation, internal rotation
Active shoulder flexion, abduction, adduction, extension, external rotation,internal rotation of the affected shoulder were measured in degrees with a standard goniometer by the masked physician. The pretreatment value was subtracted from the week-4 value. A positive result indicates an increase in the available range of motion.
Measured: Before the first treatment session and at the end of the four-week treatment course.
Increase in active wrist flexion, extension, radial deviation, ulnar deviation
Active flexion, extension, radial deviation,ulnar deviation of the affected wrist were measured in degrees with a standard goniometer by the masked physician. Changes were calculated as the week-4 value minus the pretreatment value. Positive values indicate a gain in range of motion.
Measured: Before the first treatment session and at the end of the four-week treatment course.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start5 Oct 2022
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer LymphedemaStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlknur Albayrak Gezer, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862296
- Sponsor's protocol ID
- E-70632468-050.01.04-372389
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data supporting the published findings will be made available to researchers following approval of a reasonable request submitted to the corresponding author. Requests will be assessed by the study team. Any data transfer will be subject to applicable institutional and ethical requirements and must be consistent with participant consent and the protection of participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Complex Decongestive Therapy and Extracorporeal Shock Wave Therapy in Patients With Lymphedema
- ClinicalTrials.gov ID
- NCT07862296
- Acronym / sponsor ID
- E-70632468-050.01.04-372389
- Conditions
- Breast Cancer Lymphedema
- Keywords
- Upper-limb lymphedema, Radial extracorporeal shock wave therapy, Complex decongestive therapy, Ultrasonography, Cancer rehabilitation, Arm function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 7 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.
Arm swelling can persist after breast cancer treatment and may interfere with comfort, movement, and everyday activities. Decongestive care combines several approaches to manage this swelling. This study examined whether adding radial shock wave treatment changed short-term outcomes compared with decongestive care alone.
Twenty-one adults with stage 2 or stage 3 lymphedema affecting one arm were assigned to two treatment groups. Both groups were allocated to a four-week decongestive program. The combined-treatment schedule also included twelve shock wave sessions. Assessments before and after treatment covered arm size, the thickness of the skin and the tissue beneath it, pain, difficulty using the arm, lymphedema-related quality of life, and shoulder and wrist movement. A physician who did not know the treatment assignment performed the physical and ultrasound measurements.
Detailed description
This single-center study evaluated a noninvasive addition to intensive rehabilitation for unilateral upper-limb lymphedema following breast cancer treatment. It was conducted at the Physical Medicine and Rehabilitation Clinic of Selcuk University Faculty of Medicine Hospital in Konya, Türkiye.
The comparison was designed to examine the contribution of radial shock wave treatment separately from the decongestive program received by both groups. Overall limb measurements and regional ultrasound assessments were used to examine different aspects of the response to treatment. Questionnaires and joint measurements provided complementary information about symptoms, everyday arm use, and mobility.
The assessment schedule included examinations before treatment and at the end of the four-week course. Circumference measurements were also obtained weekly during the intervention period. The same physician performed the objective assessments without knowledge of group assignment. Participants and the personnel providing treatment were aware of the assigned intervention.
The Selcuk University Faculty of Medicine Local Ethics Committee approved the study on October 4, 2022, under decision number 2022/410. Each participant provided written consent. This record describes a study that had already been completed before its initial submission to ClinicalTrials.gov.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decongestive care with radial shock wave therapy | Experimental | Other: Complex decongestive therapy, Device: Radial extracorporeal shock wave therapyParticipants were allocated to a four-week course of complex decongestive therapy with additional radial extracorporeal shock wave treatment. Decongestive sessions were scheduled on five days each week, and shock wave sessions on three days each week. |
| Decongestive care alone | Active comparator | Other: Complex decongestive therapyParticipants were allocated to the same four-week complex decongestive program, without shock wave treatment. The planned schedule consisted of five treatment days per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older.
- A history of breast cancer with unilateral upper-limb lymphedema established by clinical evaluation and lymphoscintigraphy.
- Stage 2 or stage 3 lymphedema according to the International Society of Lymphology classification.
- Availability of electronic medical records containing sex, age, weight, height, body mass index, occupation, comorbid conditions, medication use, and chemotherapy and radiotherapy history.
- Written informed consent to participate.
Key exclusion criteria (4 listed)
- Active malignancy.
- Ongoing chemotherapy or radiotherapy.
- Clinical evidence of infection in the affected upper limb.
- Advanced cardiac or renal failure.
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 |
|---|---|---|
| Complex decongestive therapyThe planned course comprised four weeks of treatment on five days per week. Components included manual lymphatic drainage, multilayer short-stretch bandaging, skin care, and therapeutic exercise. Exercise activities addressed breathing, posture, shoulder-girdle movement, gentle stretching, and low-intensity active movement of the upper limb and fingers. Movements were performed slowly within a pain-free range while the compression bandages were in place. | Other | Decongestive care alone, Decongestive care with radial shock wave therapy |
| Radial extracorporeal shock wave therapyAn Intelect RPW Lite system (Chattanooga) was used to deliver radial pressure pulses with the participant lying supine. The scheduled regimen consisted of three sessions per week for four weeks. Each session used a pressure setting of 2 bar and a frequency of 4 Hz, with 2,500 pulses in total. Of these, 750 were directed to the axillary region and 250 to the cubital region; the remaining 1,500 were distributed across the arm, forearm, and hand. | Device | Decongestive care with radial shock wave therapy |
Primary outcome
Reduction in calculated affected upper-limb volume
Time frame: Before the first treatment session and at the end of the four-week treatment course.
Volume of the affected upper limb was estimated from circumference measurements using the truncated-cone method and expressed in liters. The week-4 volume was subtracted from the pretreatment volume. A positive value indicates a reduction in calculated limb volume.
16 secondary outcomes
Reduction in arm circumference 10 cm above the cubital fossa
Time frame: Before the first treatment session and at the end of the four-week treatment course.
Reduction in forearm circumference 10 cm below the cubital fossa
Time frame: Before the first treatment session and at the end of the four-week treatment course.
Reduction in skin thickness at 10 cm proximal to the cubital fossa
Time frame: Before the first treatment session and at the end of the four-week treatment course.
Reduction in skin thickness at the cubital fossa
Time frame: Before the first treatment session and at the end of the four-week treatment course.
Reduction in skin thickness at 10 cm distal to the cubital fossa
Time frame: Before the first treatment session and at the end of the four-week treatment course.
Reduction in subcutaneous tissue thickness at 10 cm proximal to the cubital fossa
Time frame: Before the first treatment session and at the end of the four-week treatment course.
Reduction in subcutaneous tissue thickness at the cubital fossa
Time frame: Before the first treatment session and at the end of the four-week treatment course.
Reduction in subcutaneous tissue thickness at 10 cm distal to the cubital fossa
Time frame: Before the first treatment session and at the end of the four-week treatment course.
Reduction in the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score
Time frame: Before the first treatment session and at the end of the four-week treatment course.
Reduction in upper-limb pain on the Visual Analog Scale
Time frame: Before the first treatment session and at the end of the four-week treatment course.
Reduction in the Lymphedema Quality of Life Questionnaire-Arm function domain score
Time frame: Before the first treatment session and at the end of the four-week treatment course.
Reduction in the Lymphedema Quality of Life Questionnaire-Arm appearance domain score
Time frame: Before the first treatment session and at the end of the four-week treatment course.
Reduction in the Lymphedema Quality of Life Questionnaire-Arm symptoms domain score
Time frame: Before the first treatment session and at the end of the four-week treatment course.
Reduction in the Lymphedema Quality of Life Questionnaire-Arm mood domain score
Time frame: Before the first treatment session and at the end of the four-week treatment course.
Increase in active shoulder flexion, abduction, adduction, extension, external rotation, internal rotation
Time frame: Before the first treatment session and at the end of the four-week treatment course.
Increase in active wrist flexion, extension, radial deviation, ulnar deviation
Time frame: Before the first treatment session and at the end of the four-week treatment course.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified participant-level data supporting the published findings will be made available to researchers following approval of a reasonable request submitted to the corresponding author. Requests will be assessed by the study team. Any data transfer will be subject to applicable institutional and ethical requirements and must be consistent with participant consent and the protection of participant confidentiality.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex decongestive therapy and Radial extracorporeal shock wave therapy in people with Breast Cancer Lymphedema, run by Selcuk University 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 7 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in calculated affected upper-limb volume (time frame: Before the first treatment session and at the end of the four-week treatment course.). 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 7 Oct 2026.