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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
104
The MLS M6 laser from ASA will be used to apply the laser therapy.
Patients will receive twice weekly MLT executed by trained physiotherapist
Hasselt University
Hasselt, Limburg, Belgium
RECRUITINGJessa Ziekenhuis
Hasselt, Limburg, Belgium
RECRUITINGArm 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline
ISL classification
The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.
Time frame: Week 9
ISL classification
The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.
Time frame: Week 18
ISL classification
The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 6 month follow-up
Pain assessment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 18
Depression, anxiety and stress
The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 12 month follow-up