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

Not Applicable

Completed

• Conditions: Lymphedema
• Interventions: Device: Multi-waved Locked System Laser; Device: Cold Compression therapy; Other: complete decongestive therapy

• Registration Number: NCT05911854
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-21
• Primary Completion: 2023-05-06
• Status Verified: 2023-06
• Study Completion: 2023-06-05
• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-16
• Last Update Submitted: 2023-06-16
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group (A) Multi-waved Locked System Laser group	complete decongestive therapy	-
Group (C) Control group	complete decongestive therapy	-
Study group (A) Multi-waved Locked System Laser group	Multi-waved Locked System Laser	-
Study group (B) Cold Compression Therapy group	Cold Compression therapy	-
Study group (B) Cold Compression Therapy group	complete decongestive therapy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine, Faculty of Medicine, Cairo University; 🇪🇬 Cairo, Egypt