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

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05911854
• Other study ID #: 004539
• Status: Completed
• Phase: N/A
• Start date: January 21, 2023
• Est. completion date: June 5, 2023

Study information

• Verified date: June 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 5, 2023
• Est. primary completion date: May 6, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Lymphedema

Intervention

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.
• 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:
• 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)

Locations

Country	Name	City	State
Egypt	Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine, Faculty of Medicine, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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