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Recruiting NCT04690439

Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema

No phase Interventional Breast Cancer Breast Cancer Related Lymphedema Lymphedema of Upper Arm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Photobiomodulation therapy (PBMT), Manual Lymphatic drainage.
Who it may be relevant to
Registry conditions: Breast Cancer, Breast Cancer Related Lymphedema, Lymphedema of Upper Arm. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Arm circumference and volume [Time frame: Baseline]
  • Arm circumference and volume [Time frame: week 5]
  • Arm circumference and volume [Time frame: week 9]
  • Arm circumference and volume [Time frame: Week 14]
  • Arm circumference and volume [Time frame: Week 18]
  • Arm circumference and volume [Time frame: 3 month follow-up]
  • Arm circumference and volume [Time frame: 6 month follow-up]
  • Arm circumference and volume [Time frame: 9 month follow-up]
  • Arm circumference and volume [Time frame: 12 month follow-up]
  • Arm mobility measurement [Time frame: Baseline]
Secondary outcome measures (12)
  • Pain assessment [Time frame: Baseline]
  • Pain assessment [Time frame: week 5]
  • Pain assessment [Time frame: week 9]
  • Pain assessment [Time frame: week 14]
  • Pain assessment [Time frame: week 18]
  • Pain assessment [Time frame: 3 month follow-up]
  • Pain assessment [Time frame: 6 month follow-up]
  • Pain assessment [Time frame: 9 month follow-up]
  • Pain assessment [Time frame: 12 month follow-up]
  • Quality of life assessment [Time frame: Baseline]
  • Quality of life assessment [Time frame: week 5]
  • Quality of life assessment [Time frame: week 9]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Belgium · 2 centers
  • Hasselt University — Hasselt
  • Jessa Ziekenhuis — Hasselt

Identifiers

NCT: NCT04690439 · 2020-154 · B2342020000029

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗