Efficacy of Multi-waved Locked System Laser Versus Cold Compression Therapy on Breast Cancer-related Lymphoedema

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Multi-waved Locked System Laser Versus Cold Compression Therapy on Breast Cancer-related Lymphoedema: Randomized Controlled Trial

Conditions
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Lymphedema

Intervention / Treatment
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* Device: Multi-waved Locked System Laser
* Device: Cold Compression therapy
* Other: complete decongestive therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group (A) Multi-waved Locked System Laser group<br> | Device: Multi-waved Locked System Laser<br>* 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.<br>* Other names: M6 therapy;Other: complete decongestive therapy<br>* 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)<br>|
| Experimental: Study group (B) Cold Compression Therapy group<br> | Device: Cold Compression therapy<br>* The BioCryo Cold Compression System is a cold therapy pneumatic compression device that safely administers sequential, gradient pneumatic compression and CryoTherapy combined.<br>* Other names: BioCryo Cold Compression System;Other: complete decongestive therapy<br>* 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)<br>|
| Active Comparator: Group (C) Control group<br> | Other: complete decongestive therapy<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline |