Efficacy of Multi-waved Locked System Laser Versus Cold Compression Therapy on Breast Cancer-related Lymphoedema
NCT ID: NCT05911854
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2023-01-21
2023-06-05
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Study group (A) Multi-waved Locked System Laser group
Multi-waved Locked System Laser
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.
complete decongestive therapy
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 (B) Cold Compression Therapy group
Cold Compression therapy
The BioCryo Cold Compression System is a cold therapy pneumatic compression device that safely administers sequential, gradient pneumatic compression and CryoTherapy combined.
complete decongestive therapy
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)
Group (C) Control group
complete decongestive therapy
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)
Interventions
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Multi-waved Locked System Laser
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 therapy
The BioCryo Cold Compression System is a cold therapy pneumatic compression device that safely administers sequential, gradient pneumatic compression and CryoTherapy combined.
complete decongestive therapy
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Sherine Omar Abdelaziz Mohamed Elsherif
assistant lecturer
Principal Investigators
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Mohamed H El-Gendy, professor
Role: STUDY_CHAIR
Cairo University
Locations
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Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine, Faculty of Medicine, Cairo University
Cairo, , Egypt
Countries
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Other Identifiers
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004539
Identifier Type: -
Identifier Source: org_study_id
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