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Completed

NCT Number: NCT05911854

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

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.

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Key information

Conditions

Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Cairo, 11553, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multi-waved Locked System Laser

Device

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

Cold Compression therapy

Device

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

Complete Decongestive Therapy

Other

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 outcomes

  1. 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

  2. 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

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

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 22, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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