Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema

Breast Cancer Clinical Trial

— LymphLight  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04690439
• Other study ID #: 2020-154
• Secondary ID: B2342020000029
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: February 2028

Study information

• Verified date: February 2023
• Source: Jessa Hospital
• Contact: Jolien Robijns, PhD
• Phone: 011337229
• Email: jolien.robijns[@]jessazh.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: February 2028
• Est. primary completion date: February 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Lymphedema
• Breast Cancer Related Lymphedema
• Breast Neoplasms
• Lymphedema
• Lymphedema of Upper Arm

Intervention

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

Locations

Country	Name	City	State
Belgium	Hasselt University	Hasselt	Limburg
Belgium	Jessa Ziekenhuis	Hasselt	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Jessa Hospital	Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	1 year follow up
Other	Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	2 years follow up
Other	Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	3 years follow up
Other	Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	4 years follow up
Other	Appearance and date of secondary tumors	The possible appearance and date of secondary tumors will be collected.	5 years follow up
Other	Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	1 year follow up
Other	Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	2 years follow up
Other	Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	3 years follow up
Other	Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	4 years follow up
Other	Appearance and date of distant metastasis	The possible appearance and date of distant metastasis will be collected.	5 years follow up
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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)/12p 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
Primary	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)/12p 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
Primary	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)/12p 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
Primary	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)/12p 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
Primary	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)/12p 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
Primary	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)/12p 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
Primary	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)/12p 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
Primary	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)/12p 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
Primary	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)/12p 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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	ISL classification	The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.	Baseline
Primary	ISL classification	The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.	Week 9
Primary	ISL classification	The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.	Week 18
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Website of the Limburg Oncologic Laser Institute