Lymphedema
Conditions
Brief 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. * 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.
Interventions
DEVICEMulti-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.
DEVICECold 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 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)
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the change in lymphatic flow using lymphoscintigraphy pre and post treatment | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of Lymphedema Life Impact Scale scores pre and post treatment | Baseline | 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. |
Countries
Egypt
Outcome results
None listed