NCT05911854

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

June 9, 2023

Last Update Submit

June 16, 2023

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • The change of Lymphedema Life Impact Scale scores pre and post treatment

    Baseline

Study Arms (3)

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

EXPERIMENTAL
Device: Multi-waved Locked System LaserOther: complete decongestive therapy

Study group (B) Cold Compression Therapy group

EXPERIMENTAL
Device: Cold Compression therapyOther: complete decongestive therapy

Group (C) Control group

ACTIVE COMPARATOR
Other: complete decongestive therapy

Interventions

Multi-waved Locked System LaserDEVICE

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.

Also known as: M6 therapy
Study group (A) Multi-waved Locked System Laser group
Cold Compression therapyDEVICE

The BioCryo Cold Compression System is a cold therapy pneumatic compression device that safely administers sequential, gradient pneumatic compression and CryoTherapy combined.

Also known as: BioCryo Cold Compression System
Study group (B) Cold Compression Therapy group
complete decongestive therapyOTHER

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)

Group (C) Control groupStudy group (A) Multi-waved Locked System Laser groupStudy group (B) Cold Compression Therapy group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cairo, 11553, Egypt

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Mohamed H El-Gendy, professor

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

June 9, 2023

First Posted

June 22, 2023

Study Start

January 21, 2023

Primary Completion

May 6, 2023

Study Completion

June 5, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

EG(1)