Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema (LymphLight)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Lymphedema of Upper Arm; Breast Cancer Related Lymphedema
• Intervention / Treatment: Device: Photobiomodulation therapy (PBMT); Procedure: Manual Lymphatic drainage

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.

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jolien Robijns, PhD; Phone Number: 011337229; Email: jolien.robijns@jessazh.be

Study Locations

• Belgium
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Recruiting
      • Hasselt University
      • Contact: Jolien Robijns, PhD; Email: jolien.robijns@uhasselt.be
      • Principal Investigator: Jeroen Mebis, MD, PhD
      • Sub-Investigator: Joy Lodewijckx, MSc
    • Hasselt, Limburg, Belgium, 3500
      • Recruiting
      • Jessa Ziekenhuis
      • Principal Investigator: Jeroen Mebis, MD, PhD
      • Sub-Investigator: Joy Lodewijckx, MSc
      • Contact: Jolien Robijns, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Group A will receive first PBM + manual lymphatic drainage for 9 weeks (2 sessions/week), followed by 9 weeks only manual lymphatic drainage.	Device: Photobiomodulation therapy (PBMT); The MLS M6 laser from ASA will be used to apply the laser therapy.; Other Names: LLLT; Procedure: Manual Lymphatic drainage; Patients will receive twice weekly MLT executed by trained physiotherapist; Other Names: MLT
Active Comparator: Group B; Group B will first receive only manual lymphatic drainage for 9 weeks, followed by the combination of PBM and manual lymphatic drainage for 9 weeks (2x/week).	Device: Photobiomodulation therapy (PBMT); The MLS M6 laser from ASA will be used to apply the laser therapy.; Other Names: LLLT; Procedure: Manual Lymphatic drainage; Patients will receive twice weekly MLT executed by trained physiotherapist; Other Names: MLT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arm circumference and volume	The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter	Baseline
Arm circumference and volume	The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter	week 5
Arm circumference and volume	The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter	week 9
Arm circumference and volume	The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter	Week 14
Arm circumference and volume	The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter	Week 18
Arm circumference and volume	The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter	3 month follow-up
Arm circumference and volume	The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter	6 month follow-up
Arm circumference and volume	The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter	9 month follow-up
Arm circumference and volume	The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter	12 month follow-up
Arm mobility measurement	A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.	Baseline
Arm mobility measurement	A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.	week 5
Arm mobility measurement	A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.	week 9
Arm mobility measurement	A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.	week 14
Arm mobility measurement	A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.	week 18
Arm mobility measurement	A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.	3 month follow-up
Arm mobility measurement	A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.	6 month follow-up
Arm mobility measurement	A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.	9 month follow-up
Arm mobility measurement	A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.	12 month follow-up
Activity and participation	The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities.	Baseline
Activity and participation	The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability).	week 5
Activity and participation	The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability).	week 9
Activity and participation	The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability).	week 14
Activity and participation	The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability).	week 18
Activity and participation	The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability).	3 month follow-up
Activity and participation	The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability).	6 month follow-up
Activity and participation	The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability).	9 month follow-up
Activity and participation	The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability).	12 month follow-up
ISL classification	The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.	Baseline
ISL classification	The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.	Week 9
ISL classification	The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.	Week 18
ISL classification	The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.	3 month follow-up
ISL classification	The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.	6 month follow-up
ISL classification	The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.	9 month follow-up
ISL classification	The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.	12 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony).	Baseline
Pain assessment	The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony).	week 5
Pain assessment	The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony).	week 9
Pain assessment	The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony).	week 14
Pain assessment	The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony).	week 18
Pain assessment	The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony).	3 month follow-up
Pain assessment	The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony).	6 month follow-up
Pain assessment	The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony).	9 month follow-up
Pain assessment	The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony).	12 month follow-up
Quality of life assessment	The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem).	Baseline
Quality of life assessment	The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem).	week 5
Quality of life assessment	The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem).	week 9
Quality of life assessment	The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem).	week 14
Quality of life assessment	The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem).	week 18
Quality of life assessment	The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem).	3 month follow-up
Quality of life assessment	The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem).	6 month follow-up
Quality of life assessment	The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem).	9 month follow-up
Quality of life assessment	The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem).	12 month follow-up
Depression, anxiety and stress	The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress.	Baseline
Depression, anxiety and stress	The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress.	week 5
Depression, anxiety and stress	The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress.	week 9
Depression, anxiety and stress	The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress.	week 14
Depression, anxiety and stress	The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress.	week 18
Depression, anxiety and stress	The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21).	3 month follow-up
Depression, anxiety and stress	The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress.	6 month follow-up
Depression, anxiety and stress	The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress.	9 month follow-up
Depression, anxiety and stress	The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress.	12 month follow-up
Patients' satisfaction with the therapeutic intervention	The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention and their global satisfaction with the therapeutic intervention, using the Numerical Rating Scale (NRS). This is scored on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied).	At week 9
Patients' satisfaction with the therapeutic intervention	The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention and their global satisfaction with the therapeutic intervention, using the Numerical Rating Scale (NRS). This is scored on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied).	At week 18
Patients' satisfaction with the therapeutic intervention	The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention and their global satisfaction with the therapeutic intervention, using the Numerical Rating Scale (NRS). This is scored on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied).	3 month follow-up
Patients' satisfaction with the therapeutic intervention	The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention and their global satisfaction with the therapeutic intervention, using the Numerical Rating Scale (NRS). This is scored on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied).	6 month follow-up
Patients' satisfaction with the therapeutic intervention	The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention and their global satisfaction with the therapeutic intervention, using the Numerical Rating Scale (NRS). This is scored on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied).	9 month follow-up
Patients' satisfaction with the therapeutic intervention	The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention and their global satisfaction with the therapeutic intervention, using the Numerical Rating Scale (NRS). This is scored on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied).	12 month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
General patient-, disease-, and treatment-related information	General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).	Baseline
General patient-, disease-, and treatment-related information	General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).	3 month follow-up
General patient-, disease-, and treatment-related information	General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).	6 month follow-up
General patient-, disease-, and treatment-related information	General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).	9 month follow-up
General patient-, disease-, and treatment-related information	General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).	12 month follow-up
Appearance and date of local and regional recurrence	The possible appearance and date of local and/or regional recurrence will be collected.	12 month follow-up
Appearance and date of local and regional recurrence	The possible appearance and date of local and/or regional recurrence will be collected.	2 years follow up
Appearance and date of local and regional recurrence	The possible appearance and date of local and/or regional recurrence will be collected.	3 years follow up
Appearance and date of local and regional recurrence	The possible appearance and date of local and/or regional recurrence will be collected.	4 years follow up
Appearance and date of local and regional recurrence	The possible appearance and date of local and/or regional recurrence will be collected.	5 years follow up
Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	1 year follow up
Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	2 years follow up
Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	3 years follow up
Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	4 years follow up
Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	5 years follow up
Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	1 year follow up
Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	2 years follow up
Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	3 years follow up
Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	4 years follow up
Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	5 years follow up
Date of death of any cause	If the patient dies within the first year after the treatment, their date of death will be collected.	1 year follow up
Date of death of any cause	If the patient dies within 2 years after the treatment, their date of death will be collected.	2 years follow up
Date of death of any cause	If the patient dies within 3 years after the treatment, their date of death will be collected.	3 years post treatment
Date of death of any cause	If the patient dies within 4 years after the treatment, their date of death will be collected.	4 years follow up
Date of death of any cause	If the patient dies within 5 years after the treatment, their date of death will be collected.	5 years follow up

Collaborators and Investigators

• Sponsor: Jessa Hospital
• Collaborators: Hasselt University
• Investigators: Principal Investigator: Jeroen Mebis, MD, PhD, Jessa Hospital

Publications and helpful links

Helpful Links

• Website of the Limburg Oncologic Laser Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Anticipated): February 1, 2028
• Study Completion (Anticipated): February 1, 2028

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Lymphedema; Breast cancer; Photobiomodulation
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: 2020-154; B2342020000029 (Registry Identifier: Belgian Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No