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

Primary Purpose

Lymphedema

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Multi-waved Locked System Laser
Cold Compression therapy
complete decongestive therapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

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

Study group (B) Cold Compression Therapy group

Group (C) Control group

Arm Description

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.

Full Information

First Posted
June 9, 2023
Last Updated
June 16, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05911854
Brief Title
Efficacy of Multi-waved Locked System Laser Versus Cold Compression Therapy on Breast Cancer-related Lymphoedema
Official Title
Efficacy of Multi-waved Locked System Laser Versus Cold Compression Therapy on Breast Cancer-related Lymphoedema: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 21, 2023 (Actual)
Primary Completion Date
May 6, 2023 (Actual)
Study Completion Date
June 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group (A) Multi-waved Locked System Laser group
Arm Type
Experimental
Arm Title
Study group (B) Cold Compression Therapy group
Arm Type
Experimental
Arm Title
Group (C) Control group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Multi-waved Locked System Laser
Other Intervention Name(s)
M6 therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Cold Compression therapy
Other Intervention Name(s)
BioCryo Cold Compression System
Intervention Description
The BioCryo Cold Compression System is a cold therapy pneumatic compression device that safely administers sequential, gradient pneumatic compression and CryoTherapy combined.
Intervention Type
Other
Intervention Name(s)
complete decongestive therapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
Evaluation of the change in lymphatic flow using lymphoscintigraphy pre and post treatment
Description
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
Time Frame
Baseline
Title
The change of Volumetric measurement of the arm pre and post treatment
Description
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
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
The change of Lymphedema Life Impact Scale scores pre and post treatment
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed H El-Gendy, professor
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Kasr El-Einy Center of Radiation Oncology and Nuclear Medicine, Faculty of Medicine, Cairo University
City
Cairo
ZIP/Postal Code
11553
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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