Clinical trial NCT04690439: Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema
Official title: Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Breast Cancer-Related Lymphedema: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast Cancer Related Lymphedema
Lymphedema of Upper Arm
Keywords: Lymphedema
Breast cancer
Photobiomodulation
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
Collaborators: name: Hasselt University
First posted: 2020-12-30
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized, controlled cross-over trial
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Arm circumference and volume
timeFrame: Baseline
measure: Arm circumference and volume
timeFrame: week 5
measure: Arm circumference and volume
timeFrame: week 9
measure: Arm circumference and volume
timeFrame: Week 14
measure: Arm circumference and volume
timeFrame: Week 18
measure: Arm circumference and volume
timeFrame: 3 month follow-up
measure: Arm circumference and volume
timeFrame: 6 month follow-up
measure: Arm circumference and volume
timeFrame: 9 month follow-up
measure: Arm circumference and volume
timeFrame: 12 month follow-up
measure: Arm mobility measurement
timeFrame: Baseline
measure: Arm mobility measurement
timeFrame: week 5
measure: Arm mobility measurement
timeFrame: week 9
measure: Arm mobility measurement
timeFrame: week 14
measure: Arm mobility measurement
timeFrame: week 18
measure: Arm mobility measurement
timeFrame: 3 month follow-up
measure: Arm mobility measurement
timeFrame: 6 month follow-up
measure: Arm mobility measurement
timeFrame: 9 month follow-up
measure: Arm mobility measurement
timeFrame: 12 month follow-up
measure: Activity and participation
timeFrame: Baseline
measure: Activity and participation
timeFrame: week 5
measure: Activity and participation
timeFrame: week 9
measure: Activity and participation
timeFrame: week 14
measure: Activity and participation
timeFrame: week 18
measure: Activity and participation
timeFrame: 3 month follow-up
measure: Activity and participation
timeFrame: 6 month follow-up
measure: Activity and participation
timeFrame: 9 month follow-up
measure: Activity and participation
timeFrame: 12 month follow-up
measure: ISL classification
timeFrame: Baseline
measure: ISL classification
timeFrame: Week 9
measure: ISL classification
timeFrame: Week 18
measure: ISL classification
timeFrame: 3 month follow-up
measure: ISL classification
timeFrame: 6 month follow-up
measure: ISL classification
timeFrame: 9 month follow-up
measure: ISL classification
timeFrame: 12 month follow-up
Secondary outcomes:
measure: Pain assessment
timeFrame: Baseline
measure: Pain assessment
timeFrame: week 5
measure: Pain assessment
timeFrame: week 9
measure: Pain assessment
timeFrame: week 14
measure: Pain assessment
timeFrame: week 18
measure: Pain assessment
timeFrame: 3 month follow-up
measure: Pain assessment
timeFrame: 6 month follow-up
measure: Pain assessment
timeFrame: 9 month follow-up
measure: Pain assessment
timeFrame: 12 month follow-up
measure: Quality of life assessment
timeFrame: Baseline
measure: Quality of life assessment
timeFrame: week 5
measure: Quality of life assessment
timeFrame: week 9
measure: Quality of life assessment
timeFrame: week 14
measure: Quality of life assessment
timeFrame: week 18
measure: Quality of life assessment
timeFrame: 3 month follow-up
measure: Quality of life assessment
timeFrame: 6 month follow-up
measure: Quality of life assessment
timeFrame: 9 month follow-up
measure: Quality of life assessment
timeFrame: 12 month follow-up
measure: Depression, anxiety and stress
timeFrame: Baseline
measure: Depression, anxiety and stress
timeFrame: week 5
measure: Depression, anxiety and stress
timeFrame: week 9
measure: Depression, anxiety and stress
timeFrame: week 14
measure: Depression, anxiety and stress
timeFrame: week 18
measure: Depression, anxiety and stress
timeFrame: 3 month follow-up
measure: Depression, anxiety and stress
timeFrame: 6 month follow-up
measure: Depression, anxiety and stress
timeFrame: 9 month follow-up
measure: Depression, anxiety and stress
timeFrame: 12 month follow-up
measure: Patients' satisfaction with the therapeutic intervention
timeFrame: At week 9
measure: Patients' satisfaction with the therapeutic intervention
timeFrame: At week 18
measure: Patients' satisfaction with the therapeutic intervention
timeFrame: 3 month follow-up
measure: Patients' satisfaction with the therapeutic intervention
timeFrame: 6 month follow-up
measure: Patients' satisfaction with the therapeutic intervention
timeFrame: 9 month follow-up
measure: Patients' satisfaction with the therapeutic intervention
timeFrame: 12 month follow-up
Other outcomes:
measure: General patient-, disease-, and treatment-related information
timeFrame: Baseline
measure: General patient-, disease-, and treatment-related information
timeFrame: 3 month follow-up
measure: General patient-, disease-, and treatment-related information
timeFrame: 6 month follow-up
measure: General patient-, disease-, and treatment-related information
timeFrame: 9 month follow-up
measure: General patient-, disease-, and treatment-related information
timeFrame: 12 month follow-up
measure: Appearance and date of local and regional recurrence
timeFrame: 12 month follow-up
measure: Appearance and date of local and regional recurrence
timeFrame: 2 years follow up
measure: Appearance and date of local and regional recurrence
timeFrame: 3 years follow up
measure: Appearance and date of local and regional recurrence
timeFrame: 4 years follow up
measure: Appearance and date of local and regional recurrence
timeFrame: 5 years follow up
measure: Appearance and date of secondary tumors
timeFrame: 1 year follow up
measure: Appearance and date of secondary tumors
timeFrame: 2 years follow up
measure: Appearance and date of secondary tumors
timeFrame: 3 years follow up
measure: Appearance and date of secondary tumors
timeFrame: 4 years follow up
measure: Appearance and date of secondary tumors
timeFrame: 5 years follow up
measure: Appearance and date of distant metastasis
timeFrame: 1 year follow up
measure: Appearance and date of distant metastasis
timeFrame: 2 years follow up
measure: Appearance and date of distant metastasis
timeFrame: 3 years follow up
measure: Appearance and date of distant metastasis
timeFrame: 4 years follow up
measure: Appearance and date of distant metastasis
timeFrame: 5 years follow up
measure: Date of death of any cause
timeFrame: 1 year follow up
measure: Date of death of any cause
timeFrame: 2 years follow up
measure: Date of death of any cause
timeFrame: 3 years post treatment
measure: Date of death of any cause
timeFrame: 4 years follow up
measure: Date of death of any cause
timeFrame: 5 years follow up
Locations:
city: Hasselt
country: Belgium
facility: Hasselt University
state: Limburg
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
state: Limburg
Study officials:
affiliation: Jessa Hospital
name: Jeroen Mebis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: