Lymphedema, Breast CancerNCT06415396
Effects of Extracorporeal Shock Wave Therapy (ESWT) and Low Intensity Laser Therapy (LLLT) Added to Complete Decongestive Therapy (CDT) on Extremity Volume, Pain Intensity, Functional Status and Quality of Life in Patients With Postmastectomy Stage 2 Lymphedema
A study testing Complete Decongestive Therapy, ESWT and LLLT in people with Lymphedema, Breast Cancer, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to comparatively investigate the effects of ESWT and LLLT added to conventional CDT (which is the standard treatment for breast cancer-related lymphedema) on patients' limb volume, pain intensity, functional status and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Lymphedema, Breast Cancer
- What is being tested?
- Complete Decongestive Therapy, ESWT and LLLT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 25 Jun 2023
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with unilateral lymphedema after breast cancer-related surgery Patients whose chemotherapy and radiotherapy protocols have been completed Patients with stage 2 lymphedema according to ISL staging
Who cannot join
- Patients with arm edema before breast cancer
- Patients with ongoing chemotherapy and radiotherapy Those with metastatic breast cancer Patients with acute infection Patients with BMI >35 Patients with pregnancy Patients who have previously received KDT Patients with active cancer Patients with recurrence or metastasis of breast cancer on follow-up imaging Those with decompensated heart failure Those with kidney failure Patients with liver failure Patients with a history of deep vein thrombosis in the last 3 months Those who are allergic to the dressing materials to be applied Patients with active infection or open wound on their extremities Those with cognitive impairment Patients with sensory deficits Immobilized patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara bilkent City Hospiatal Physical Therapy and Rehabilitation Hospital
Ankara, Çankaya, 06800
About this study
This study aimed to comparatively investigate the effects of ESWT and LLLT added to conventional CDT (which is the standard treatment for breast cancer-related lymphedema) on patients' limb volume, pain intensity, functional status and quality of life.
Read the detailed description
after being informed study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. The patients who meet the eligibility recruitments will get treatment into three groups in conventional complet decongestive therapy (CDT) program, electrocorporeal shock wave therapy (ESWT) combined with CDT program and low level laser therapy (LLLT) combined with CDT program
- Conditions
- Lymphedema, Breast Cancer
- Being tested
- Complete Decongestive Therapy, ESWT, LLLT
- Keywords
- Lymphedema, ESWT, LLLT
- Medical subject headings
- Breast Cancer Lymphedema, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Decongestive TherapyOther
conventional CDT program consisting of MLD, compression bandage, skin care and lymphedema exercises, for a total of 15 sessions, five days a week for three weeks.
ESWTDevice
ESWT was applied to the second group for a total of 5 sessions, 2 sessions in the first two weeks and 1 session in the last week. .
LLLTDevice
In the third group, LLLT was applied for a total of 9 sessions, 3 sessions per week, in addition to conventional CDT.
| Study group | Role | What they receive |
|---|---|---|
| Complete Decongestive Therapy | Active comparator | 22 breast cancer related lymphedema patients will received complete decongestive therapy Receives: Other: Complete Decongestive Therapy |
| Complete Decongestive Therapy and ESWT | Active comparator | 22 breast cancer related lymphedema patients will received ESWT added complete decongestive therapy Receives: Other: Complete Decongestive Therapy; Device: ESWT |
| Complete Decongestive Therapy and LLLT | Active comparator | 22 breast cancer related lymphedema patients will received LLLT added complete decongestive therapy Receives: Other: Complete Decongestive Therapy; Device: LLLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extremity volumes
Upper limb Volume measured by perometer
Measured: Baseline, after three weeks
Secondary outcomes (3)
Lymphedema Quality of Life-arm (LYMQOL-arm )
quality of life questionnaire that is spesific for upper limb lymphedema
Measured: Baseline, after three weeks
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
questionnaire that shows functional status
Measured: Baseline, after three weeks
Visual Anologue Scale -Pain (VAS)
a straight line with one end meaning no pain and the other end meaning the worst pain imaginable
Measured: Baseline, after three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Dec 2021
- Primary completion20 Jun 2023
- Study completion25 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lymphedema, Breast CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge Büşra Ceylan, Ankara City Hospital Bilkent
- Investigators
- BilgeBüşra Ceylan, Medical Doctor, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415396
- Sponsor's protocol ID
- 10025145
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JH, Kim SB, Lee KW, Ha WW. Long-Term Effects of Extracorporeal Shock Wave Therapy on Breast Cancer-Related Lymphedema. J Clin Med. 2022 Nov 15;11(22):6747. doi: 10.3390/jcm11226747.
PubMed 36431224Baxter GD, Liu L, Petrich S, Gisselman AS, Chapple C, Anders JJ, Tumilty S. Low level laser therapy (Photobiomodulation therapy) for breast cancer-related lymphedema: a systematic review. BMC Cancer. 2017 Dec 7;17(1):833. doi: 10.1186/s12885-017-3852-x.
PubMed 29216916
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Extracorporeal Shock Wave Therapy (ESWT) and Low Intensity Laser Therapy (LLLT) Added to Complete Decongestive Therapy (CDT) on Extremity Volume, Pain Intensity, Functional Status and Quality of Life in Patients With Postmastectomy Stage 2 Lymphedema
- ClinicalTrials.gov ID
- NCT06415396
- Acronym / sponsor ID
- 10025145
- Conditions
- Lymphedema, Breast Cancer
- Keywords
- Lymphedema, ESWT, LLLT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 25 Jun 2023 (actual)
- First posted
- 16 May 2024 (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.
This study aimed to comparatively investigate the effects of ESWT and LLLT added to conventional CDT (which is the standard treatment for breast cancer-related lymphedema) on patients' limb volume, pain intensity, functional status and quality of life.
Detailed description
after being informed study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. The patients who meet the eligibility recruitments will get treatment into three groups in conventional complet decongestive therapy (CDT) program, electrocorporeal shock wave therapy (ESWT) combined with CDT program and low level laser therapy (LLLT) combined with CDT program
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Complete Decongestive Therapy | Active comparator | Other: Complete Decongestive Therapy22 breast cancer related lymphedema patients will received complete decongestive therapy |
| Complete Decongestive Therapy and ESWT | Active comparator | Other: Complete Decongestive Therapy, Device: ESWT22 breast cancer related lymphedema patients will received ESWT added complete decongestive therapy |
| Complete Decongestive Therapy and LLLT | Active comparator | Other: Complete Decongestive Therapy, Device: LLLT22 breast cancer related lymphedema patients will received LLLT added complete decongestive therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients with unilateral lymphedema after breast cancer-related surgery Patients whose chemotherapy and radiotherapy protocols have been completed Patients with stage 2 lymphedema according to ISL staging
Key exclusion criteria (2 listed)
- Patients with arm edema before breast cancer
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 Therapyconventional CDT program consisting of MLD, compression bandage, skin care and lymphedema exercises, for a total of 15 sessions, five days a week for three weeks. | Other | Complete Decongestive Therapy, Complete Decongestive Therapy and ESWT, Complete Decongestive Therapy and LLLT |
| ESWTESWT was applied to the second group for a total of 5 sessions, 2 sessions in the first two weeks and 1 session in the last week. . | Device | Complete Decongestive Therapy and ESWT |
| LLLTIn the third group, LLLT was applied for a total of 9 sessions, 3 sessions per week, in addition to conventional CDT. | Device | Complete Decongestive Therapy and LLLT |
Primary outcome
Extremity volumes
Time frame: Baseline, after three weeks
Upper limb Volume measured by perometer
3 secondary outcomes
Lymphedema Quality of Life-arm (LYMQOL-arm )
Time frame: Baseline, after three weeks
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Time frame: Baseline, after three weeks
Visual Anologue Scale -Pain (VAS)
Time frame: Baseline, after three weeks
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 16 May 2024.
- Background: PubMed 36431224Lee JH, Kim SB, Lee KW, Ha WW. Long-Term Effects of Extracorporeal Shock Wave Therapy on Breast Cancer-Related Lymphedema. J Clin Med. 2022 Nov 15;11(22):6747. doi: 10.3390/jcm11226747.
- Background: PubMed 29216916Baxter GD, Liu L, Petrich S, Gisselman AS, Chapple C, Anders JJ, Tumilty S. Low level laser therapy (Photobiomodulation therapy) for breast cancer-related lymphedema: a systematic review. BMC Cancer. 2017 Dec 7;17(1):833. doi: 10.1186/s12885-017-3852-x.
- Individual participant dataSharing planned: No
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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.
BilgeBüşra Ceylan, Medical Doctor principal investigator
Ankara City Hospital Bilkent
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, ESWT and LLLT in people with Lymphedema, Breast Cancer, 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 1 inclusion and 2 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 16 May 2024. 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?
Extremity volumes (time frame: Baseline, after three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06415396, which also lists 2 linked publications.
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 16 May 2024.