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

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

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.

Study Overview

• Status: Completed
• Conditions: Lymphedema
• Intervention / Treatment: Device: Multi-waved Locked System Laser; Other: complete decongestive therapy; Device: Cold Compression therapy

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11553
    • Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine, Faculty of Medicine, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group (A) Multi-waved Locked System Laser group	Device: 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.; Other Names: M6 therapy; Other: 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)
Experimental: Study group (B) Cold Compression Therapy group	Other: 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); Device: 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.; Other Names: BioCryo Cold Compression System
Active Comparator: Group (C) Control group	Other: 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Mohamed H El-Gendy, professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2023
• Primary Completion (Actual): May 6, 2023
• Study Completion (Actual): June 5, 2023

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Lymphatic Diseases; Postoperative Complications; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: 004539

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No