Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema

Официальное название

Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Breast Cancer-Related Lymphedema: a Randomized Controlled Trial

Обзор

Up to one out of five patients with breast cancer will develop lymphedema in the upper extremity after cancer treatment. Patients with breast cancer-related lymphedema (BCRL) suffer from pain, heaviness, tightness, and a decreased range of motion. Photobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and/or near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. Therefore, the aim of this study is to evaluate the effectiveness of PBMT on the management of BCRL.

Подробное описание

This aim of this study is to determine the efficacy of PBMT in combination with the institutional therapy on the management of BCRL. Therefore, we hypothesize that PBMT in combination with manual lymphatic drainage is able to reduce the limb circumference and the associated pain and improve the QoL of patients with BCRL during treatment and up to 12 months post-treatment.

Primary Objective 1: Arm circumference

The study seeks primarily to determine the effectiveness PBMT and manual lymphatic drainage in reducing the arm circumference in patients with established BCRL during PBM treatment and up to 12 months post-PBMT.

Primary Objective 2: Activity and participation

Another primary aim of this study is to evaluate the effectiveness of PBMT and manual lymphatic drainage in the enhancement of the patients' activity and participation status.

Secondary Objective 1: Pain

A secondary aim of this study is to evaluate if PBMT and manual lymphatic drainage can reduce the BCRL-related pain during PBM treatment and up to 12 months post-PBMT.

Secondary Objective 2: Quality of life

A secondary aim of this study is to evaluate if PBMT and manual lymphatic drainage can improve the patients' QoL during PBM treatment and up to 12 months post-PBMT.

Secondary Objective 3: Depression

A secondary aim of this study is to evaluate if PBMT and manual lymphatic drainage can improve the patients' mental status during PBM treatment and up to 12 months post-PBMT.

Secondary Objective 4: Patient satisfaction

A secondary aim of this study is to evaluate if patients are satisfied with PBMT and manual lymphatic drainage as a treatment for BCRL during the treatment sessions and up to 12 months post-therapy.

Secondary Objective 5: PBM safety

A secondary aim of this study is to evaluate the safety of PBM in oncologic patients up to 5 years post-PBMT.

Вмешательства

• Устройство Photobiomodulation therapy (PBMT)
  The MLS M6 laser from ASA will be used to apply the laser therapy.
• Процедура Manual Lymphatic drainage
  Patients will receive twice weekly MLT executed by trained physiotherapist

Первичные конечные точки

• Arm circumference and volume [Срок оценки: Baseline]
• Arm circumference and volume [Срок оценки: week 5]
• Arm circumference and volume [Срок оценки: week 9]
• Arm circumference and volume [Срок оценки: Week 14]
• Arm circumference and volume [Срок оценки: Week 18]
• Arm circumference and volume [Срок оценки: 3 month follow-up]
• Arm circumference and volume [Срок оценки: 6 month follow-up]
• Arm circumference and volume [Срок оценки: 9 month follow-up]
• Arm circumference and volume [Срок оценки: 12 month follow-up]
• Arm mobility measurement [Срок оценки: Baseline]

Вторичные конечные точки (12)

• Pain assessment [Срок оценки: Baseline]
• Pain assessment [Срок оценки: week 5]
• Pain assessment [Срок оценки: week 9]
• Pain assessment [Срок оценки: week 14]
• Pain assessment [Срок оценки: week 18]
• Pain assessment [Срок оценки: 3 month follow-up]
• Pain assessment [Срок оценки: 6 month follow-up]
• Pain assessment [Срок оценки: 9 month follow-up]
• Pain assessment [Срок оценки: 12 month follow-up]
• Quality of life assessment [Срок оценки: Baseline]
• Quality of life assessment [Срок оценки: week 5]
• Quality of life assessment [Срок оценки: week 9]

Критерии участия

Критерии включения

• Diagnosed with breast cancer
• Underwent ipsilateral lumpectomy or mastectomy + sentinel lymph node biopsy +/- lymph node dissection
• Underwent radiotherapy with or without chemotherapy
• Diagnosed with BCRL (i.e. International Society of Lymphology (ISL) lymphedema stage I or higher)
• Age ≥ 18 years
• Able to comply to the study protocol
• Able to sign written informed consent

Критерии исключения

• Metastatic disease
• Pregnancy
• History of surgery or trauma to the arm
• History of arm infection in the past 3 months
• Use of medications that affect body fluid (e.g., diuretics) in the last 3 months
• Severe psychological disorder or dementia
• Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бельгия · 2 центра

• Hasselt University — Hasselt
• Jessa Ziekenhuis — Hasselt

Идентификаторы

NCT: NCT04690439 · 2020-154 · B2342020000029

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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