Efficacy of Multi-waved Locked System Laser Versus Cold Compression Therapy on Breast Cancer-related Lymphoedema: Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Evaluation of the change in lymphatic flow using lymphoscintigraphy pre and post treatment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
Study group (A) Multi-waved Locked System Laser group
Intervention: Multi-waved Locked System Laser (Device)
Study group (A) Multi-waved Locked System Laser group
Intervention: complete decongestive therapy (Other)
Study group (B) Cold Compression Therapy group
Intervention: Cold Compression therapy (Device)
Study group (B) Cold Compression Therapy group
Intervention: complete decongestive therapy (Other)
Group (C) Control group
Intervention: complete decongestive therapy (Other)
Outcomes
Primary Outcomes
Evaluation of the change in lymphatic flow using lymphoscintigraphy pre and post treatment
Time Frame: 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
Time Frame: 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 Outcomes
- The change of Lymphedema Life Impact Scale scores pre and post treatment(Baseline)
Investigators
Sherine Omar Abdelaziz Mohamed Elsherif
assistant lecturer
Cairo University