Lymphedema of Upper LimbNCT06278298
Different Level of ECSWT in Post Mastectomy Lymphedema
A study testing Shockwave and CDT in people with Lymphedema of Upper Limb, run by Cairo University at 1 site in Egypt.
Trial summary
to investigate the effectiveness of different dosages of ECSW in the treatment of post mastectomy lymphedema volume and quality of life (Qol) Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Lymphedema of Upper Limb
- What is being tested?
- Shockwave and CDT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 1 Jan 2025
- 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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Criteria of selecting the patients from hospital included the following;
- Their ages ranged from 30 to 50 years.
- All patients were examined carefully by physician before the study procedure.
- All patients were free from any other pathological conditions or histories of other health abnormalities except arm lymphedema.
- They had undergone radical or modified radical mastectomy with axillary lymph node dissection with or without radiotherapy intervention.
- Only ambulant subjects without any aides will be selected.
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- The degree of lymphedema in all subjects was grade 2 to 3 according to the classification of Foldi.(Foldi et al., 2006), (Appendix II ).
- All patients will be medically stable.
- Each patient will sign a consent form which in that insures her eligibility in the study.
- All patients were treated by the same doctor and physiotherapist.
Who cannot join
- The subjects had been excluded from the study if they met one of the following criteria;
- The patients had recurrent malignancy, active infection, and clinical evidence of obstructive venous diseases.
- Patients contraindicated to ESWT due to bilateral, acute, and chronic inflammation as well as due to metastasis and poor skin condition were excluded.
- The patients had neurological or orthopedic problems, and diabetes.
- Patients with primary lymphedema.
- Cardiopulmonary disease which decrease the patient activites.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Different Levels of Energy of Extracorporeal Shock Wave Therapy in Post Masrectomy Lymphedema
to investigate the effectiveness of different dosages of ECSW in the treatment of post mastectomy lymphedema volume and quality of life (Qol)
Read the detailed description
The treatment program included two sessions per week for eight weeks. This study was approved by the ethical committee faculty of Physical Therapy Cairo University. All patients signed a consent form involves their agreement to participate in this study.
- Conditions
- Lymphedema of Upper Limb
- Being tested
- Shockwave, CDT
- Keywords
- Lymphedema, Shock wave, Breast Cancer
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShockwaveDevice
Also called CDT
CDT and different dose of shockwave
CDTOther
CDT
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Shockwave Receives: Device: Shockwave |
| Group B | Experimental | Shockwave Receives: Device: Shockwave |
| Group C | Placebo comparator | CDT Receives: Other: CDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
lymphedema volume
tape measurment
Measured: two months
skin thickness of the arm
ultrasonography
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Mar 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema of Upper LimbStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Sabry, Cairo University
- Investigators
- Haytham M Elhafez, Study director, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278298
- Sponsor's protocol ID
- REC/012/003318
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Levels of Energy of Extracorporeal Shock Wave Therapy in Post Masrectomy Lymphedema
- ClinicalTrials.gov ID
- NCT06278298
- Acronym / sponsor ID
- REC/012/003318
- Conditions
- Lymphedema of Upper Limb
- Keywords
- Lymphedema, Shock wave, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 26 Feb 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.
to investigate the effectiveness of different dosages of ECSW in the treatment of post mastectomy lymphedema volume and quality of life (Qol)
Detailed description
The treatment program included two sessions per week for eight weeks. This study was approved by the ethical committee faculty of Physical Therapy Cairo University. All patients signed a consent form involves their agreement to participate in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: ShockwaveShockwave |
| Group B | Experimental | Device: ShockwaveShockwave |
| Group C | Placebo comparator | Other: CDTCDT |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Criteria of selecting the patients from hospital included the following;
- Their ages ranged from 30 to 50 years.
- All patients were examined carefully by physician before the study procedure.
- All patients were free from any other pathological conditions or histories of other health abnormalities except arm lymphedema.
- They had undergone radical or modified radical mastectomy with axillary lymph node dissection with or without radiotherapy intervention.
Key exclusion criteria (6 listed)
- The subjects had been excluded from the study if they met one of the following criteria;
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 |
|---|---|---|
| ShockwaveAlso: CDTCDT and different dose of shockwave | Device | Group A, Group B |
| CDTCDT | Other | Group C |
Primary outcome
lymphedema volume
Time frame: two months
tape measurment
skin thickness of the arm
Time frame: two months
ultrasonography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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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.
Haytham M Elhafez study director
faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave and CDT in people with Lymphedema of Upper Limb, run by Cairo University at 1 site in Egypt.
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 10 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Feb 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
lymphedema volume (time frame: two months). The study lists 2 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 26 Feb 2024.