LymphedemaNCT05911854
Efficacy of Multi-waved Locked System Laser Versus Cold Compression Therapy on Breast Cancer-related Lymphoedema
A study testing Multi-waved Locked System Laser, Cold Compression therapy and complete decongestive therapy in people with Lymphedema, run by Cairo University at 1 site in Egypt.
Trial summary
This study was conducted: To investigate the effect of MLS Laser in the management of patients with unilateral BCRL regarding lymphatic flow, volumetric measurement and HRQL assessment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema
- What is being tested?
- Multi-waved Locked System Laser, Cold Compression therapy and complete decongestive therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jan 2023to 5 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with unilateral BCRL.
- Age of patients above 18 years old
- Patient history of modified radical mastectomy, chemotherapy and/or radiotherapy.
- Patients undertaken have history or current hormonal treatment.
- Patients with moderate lymphoedema (20-40% increase in extremity volume)
Who cannot join
- Patients who have severe co-morbid diseases.
- Presence of other cancers, cancer recurrence, lymphatic malformation, or vascular disease
- Patients who are having current chemotherapy and/or radiotherapy.
- Patients who have bilateral lymphedema, current metastases, elephantiasis, infection, lymphangiosis carcinomatosa, cellulitis, venous thrombosis, or congestive heart failure
- Patients with musculoskeletal disorders affecting upper extremity.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine, Faculty of Medicine, Cairo University
Cairo, 11553
About this study
Official title: Efficacy of Multi-waved Locked System Laser Versus Cold Compression Therapy on Breast Cancer-related Lymphoedema: Randomized Controlled Trial
This study was conducted:
- To investigate the effect of MLS Laser in the management of patients with unilateral BCRL regarding lymphatic flow, volumetric measurement and HRQL assessment.
- To investigate the effect of CCT in the management of patients with unilateral BCRL regarding lymphatic flow, volumetric measurement and HRQL assessment.
- To compare the effect of MLS Laser versus CCT in the management of patients with unilateral BCRL regarding lymphatic flow, volumetric measurement and HRQL assessment.
- Conditions
- Lymphedema
- Being tested
- Multi-waved Locked System Laser, Cold Compression therapy, complete decongestive therapy
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-waved Locked System LaserDevice
Also called M6 therapy
The M6 therapy laser is a robotized multi-target device designed to treat patients suffering pathologies affecting a wide area, and to perform automatic applications.
Cold Compression therapyDevice
Also called BioCryo Cold Compression System
The BioCryo Cold Compression System is a cold therapy pneumatic compression device that safely administers sequential, gradient pneumatic compression and CryoTherapy combined.
complete decongestive therapyOther
Complete decongestive therapy consists of:
- Meticulous skin care with the use of emollients
- Using short stretch bandages or continuous wearing of a pressure garment
- Manual lymphatic drainage therapy
- Remedial exercises (e.g., aerobic exercise, strength training, and stretching exercises)
| Study group | Role | What they receive |
|---|---|---|
| Study group (A) Multi-waved Locked System Laser group | Experimental | Not described Receives: Device: Multi-waved Locked System Laser; Other: complete decongestive therapy |
| Study group (B) Cold Compression Therapy group | Experimental | Not described Receives: Device: Cold Compression therapy; Other: complete decongestive therapy |
| Group (C) Control group | Active comparator | Not described Receives: Other: complete decongestive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the change in lymphatic flow using lymphoscintigraphy pre and post treatment
Interpretation of the results of the lymphoscintigraphy and using the contralateral limb as a healthy control with normal lymphatic function can differentiate the lymphatic flow abnormalities into 7 stages
Measured: Baseline
The change of Volumetric measurement of the arm pre and post treatment
Precise arm volume measurement is capital in the follow-up of breast cancer patients, as an early detection of BCRL can reduce the incidence of irreversible stages
Measured: Baseline
Secondary outcomes (1)
The change of Lymphedema Life Impact Scale scores pre and post treatment
The Lymphedema Life Impact Scale is a lymphedema-specific tool which measures physical (pain, heaviness, tightness, strength…), psychosocial (body image, socializing, intimate relations…) and functional (duties at home, duties at work, recreational activities…) impact upon the patients' lives, the maximum score is 68 while the minimum score is 0, where a higher score indicates a worse outcome.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start21 Jan 2023
- Primary completion6 May 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherine Omar Abdelaziz Mohamed Elsherif, Cairo University
- Investigators
- Mohamed H El-Gendy, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911854
- Sponsor's protocol ID
- 004539
- Status last verified
- Jun 2023
- First submitted
- 9 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Multi-waved Locked System Laser Versus Cold Compression Therapy on Breast Cancer-related Lymphoedema: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05911854
- Acronym / sponsor ID
- 004539
- Conditions
- Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Jan 2023 (actual)
- Primary completion
- 6 May 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 22 Jun 2023 (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 was conducted:
- To investigate the effect of MLS Laser in the management of patients with unilateral BCRL regarding lymphatic flow, volumetric measurement and HRQL assessment.
- To investigate the effect of CCT in the management of patients with unilateral BCRL regarding lymphatic flow, volumetric measurement and HRQL assessment.
- To compare the effect of MLS Laser versus CCT in the management of patients with unilateral BCRL regarding lymphatic flow, volumetric measurement and HRQL assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group (A) Multi-waved Locked System Laser group | Experimental | Device: Multi-waved Locked System Laser, Other: complete decongestive therapy |
| Study group (B) Cold Compression Therapy group | Experimental | Device: Cold Compression therapy, Other: complete decongestive therapy |
| Group (C) Control group | Active comparator | Other: complete decongestive therapy |
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)
- Female patients with unilateral BCRL.
- Age of patients above 18 years old
- Patient history of modified radical mastectomy, chemotherapy and/or radiotherapy.
- Patients undertaken have history or current hormonal treatment.
- Patients with moderate lymphoedema (20-40% increase in extremity volume)
Key exclusion criteria (5 listed)
- Patients who have severe co-morbid diseases.
- Presence of other cancers, cancer recurrence, lymphatic malformation, or vascular disease
- Patients who are having current chemotherapy and/or radiotherapy.
- Patients who have bilateral lymphedema, current metastases, elephantiasis, infection, lymphangiosis carcinomatosa, cellulitis, venous thrombosis, or congestive heart failure
- Patients with musculoskeletal disorders affecting upper extremity.
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 |
|---|---|---|
| Multi-waved Locked System LaserAlso: M6 therapyThe M6 therapy laser is a robotized multi-target device designed to treat patients suffering pathologies affecting a wide area, and to perform automatic applications. | Device | Study group (A) Multi-waved Locked System Laser group |
| Cold Compression therapyAlso: BioCryo Cold Compression SystemThe BioCryo Cold Compression System is a cold therapy pneumatic compression device that safely administers sequential, gradient pneumatic compression and CryoTherapy combined. | Device | Study group (B) Cold Compression Therapy group |
| complete decongestive therapyComplete decongestive therapy consists of: * Meticulous skin care with the use of emollients * Using short stretch bandages or continuous wearing of a pressure garment * Manual lymphatic drainage therapy * Remedial exercises (e.g., aerobic exercise, strength training, and stretching exercises) | Other | Group (C) Control group, Study group (A) Multi-waved Locked System Laser group, Study group (B) Cold Compression Therapy group |
Primary outcome
Evaluation of the change in lymphatic flow using lymphoscintigraphy pre and post treatment
Time frame: Baseline
Interpretation of the results of the lymphoscintigraphy and using the contralateral limb as a healthy control with normal lymphatic function can differentiate the lymphatic flow abnormalities into 7 stages
The change of Volumetric measurement of the arm pre and post treatment
Time frame: Baseline
Precise arm volume measurement is capital in the follow-up of breast cancer patients, as an early detection of BCRL can reduce the incidence of irreversible stages
1 secondary outcome
The change of Lymphedema Life Impact Scale scores pre and post treatment
Time frame: Baseline
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 22 Jun 2023.
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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.
Mohamed H El-Gendy, professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-waved Locked System Laser, Cold Compression therapy and complete decongestive therapy in people with Lymphedema, 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 5 inclusion and 5 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 22 Jun 2023. 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. 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?
Evaluation of the change in lymphatic flow using lymphoscintigraphy pre and post treatment (time frame: Baseline). 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 22 Jun 2023; AzTrials last refreshed its copy on 31 Oct 2026.