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

Cairo University (CU)

Status: Completed

Conditions: Lymphedema

Treatments: Other: complete decongestive therapy; Device: Cold Compression therapy; Device: Multi-waved Locked System Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT05911854

004539

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 3 patient groups

Study group (A) Multi-waved Locked System Laser group

Experimental group

Treatment:

Device: Multi-waved Locked System Laser

Other: complete decongestive therapy

Study group (B) Cold Compression Therapy group

Experimental group

Treatment:

Device: Cold Compression therapy

Other: complete decongestive therapy

Group (C) Control group

Active Comparator group

Treatment:

Other: complete decongestive therapy