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NCT Number: NCT04690439

Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema

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.

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Key information

Conditions

Breast Cancer Breast Cancer Lymphedema Breast Cancer Related Lymphedema Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Lymphedema of Upper Arm Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hasselt University, Hasselt, Limburg, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photobiomodulation therapy (PBMT)

Device

The MLS M6 laser from ASA will be used to apply the laser therapy.

Other names: LLLT

Manual Lymphatic Drainage

Procedure

Patients will receive twice weekly MLT executed by trained physiotherapist

Other names: MLT

Primary outcomes

  1. Arm circumference and volume

    Time frame: Baseline

    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

  2. Arm circumference and volume

    Time frame: week 5

    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. Arm circumference and volume

    Time frame: week 9

    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

  4. Arm circumference and volume

    Time frame: Week 14

    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

  5. Arm circumference and volume

    Time frame: Week 18

    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. Arm circumference and volume

    Time frame: 3 month follow-up

    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

  7. Arm circumference and volume

    Time frame: 6 month follow-up

    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

  8. Arm circumference and volume

    Time frame: 9 month follow-up

    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. Arm circumference and volume

    Time frame: 12 month follow-up

    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

  10. Arm mobility measurement

    Time frame: Baseline

    A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.

  11. Arm mobility measurement

    Time frame: week 5

    A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.

  12. Arm mobility measurement

    Time frame: week 9

    A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.

  13. Arm mobility measurement

    Time frame: week 14

    A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.

  14. Arm mobility measurement

    Time frame: week 18

    A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.

  15. Arm mobility measurement

    Time frame: 3 month follow-up

    A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.

  16. Arm mobility measurement

    Time frame: 6 month follow-up

    A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.

  17. Arm mobility measurement

    Time frame: 9 month follow-up

    A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.

  18. Arm mobility measurement

    Time frame: 12 month follow-up

    A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation.

  19. Activity and participation

    Time frame: Baseline

    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.

  20. Activity and participation

    Time frame: week 5

    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).

  21. Activity and participation

    Time frame: week 9

    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).

  22. Activity and participation

    Time frame: week 14

    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).

  23. Activity and participation

    Time frame: week 18

    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).

  24. Activity and participation

    Time frame: 3 month follow-up

    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).

  25. Activity and participation

    Time frame: 6 month follow-up

    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).

  26. Activity and participation

    Time frame: 9 month follow-up

    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).

  27. Activity and participation

    Time frame: 12 month follow-up

    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).

  28. ISL classification

    Time frame: Baseline

    The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.

  29. ISL classification

    Time frame: Week 9

    The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.

  30. ISL classification

    Time frame: Week 18

    The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.

  31. ISL classification

    Time frame: 3 month follow-up

    The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.

  32. ISL classification

    Time frame: 6 month follow-up

    The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.

  33. ISL classification

    Time frame: 9 month follow-up

    The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.

  34. ISL classification

    Time frame: 12 month follow-up

    The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician.

Secondary outcomes

  1. Pain assessment

    Time frame: Baseline

    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).

  2. Pain assessment

    Time frame: week 5

    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. Pain assessment

    Time frame: week 9

    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).

  4. Pain assessment

    Time frame: week 14

    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).

  5. Pain assessment

    Time frame: week 18

    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. Pain assessment

    Time frame: 3 month follow-up

    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).

  7. Pain assessment

    Time frame: 6 month follow-up

    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).

  8. Pain assessment

    Time frame: 9 month follow-up

    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. Pain assessment

    Time frame: 12 month follow-up

    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).

  10. Quality of life assessment

    Time frame: Baseline

    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).

  11. Quality of life assessment

    Time frame: week 5

    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. Quality of life assessment

    Time frame: week 9

    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).

  13. Quality of life assessment

    Time frame: week 14

    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).

  14. Quality of life assessment

    Time frame: week 18

    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).

  15. Quality of life assessment

    Time frame: 3 month follow-up

    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).

  16. Quality of life assessment

    Time frame: 6 month follow-up

    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).

  17. Quality of life assessment

    Time frame: 9 month follow-up

    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).

  18. Quality of life assessment

    Time frame: 12 month follow-up

    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).

  19. Depression, anxiety and stress

    Time frame: Baseline

    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.

  20. Depression, anxiety and stress

    Time frame: week 5

    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.

  21. Depression, anxiety and stress

    Time frame: week 9

    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.

  22. Depression, anxiety and stress

    Time frame: week 14

    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.

  23. Depression, anxiety and stress

    Time frame: week 18

    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.

  24. Depression, anxiety and stress

    Time frame: 3 month follow-up

    The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21).

  25. Depression, anxiety and stress

    Time frame: 6 month follow-up

    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.

  26. Depression, anxiety and stress

    Time frame: 9 month follow-up

    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.

  27. Depression, anxiety and stress

    Time frame: 12 month follow-up

    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.

  28. Patients' satisfaction with the therapeutic intervention

    Time frame: At week 9

    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).

  29. Patients' satisfaction with the therapeutic intervention

    Time frame: At week 18

    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).

  30. Patients' satisfaction with the therapeutic intervention

    Time frame: 3 month follow-up

    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).

  31. Patients' satisfaction with the therapeutic intervention

    Time frame: 6 month follow-up

    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).

  32. Patients' satisfaction with the therapeutic intervention

    Time frame: 9 month follow-up

    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).

  33. Patients' satisfaction with the therapeutic intervention

    Time frame: 12 month follow-up

    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).

Other outcomes

  1. General patient-, disease-, and treatment-related information

    Time frame: Baseline

    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).

  2. General patient-, disease-, and treatment-related information

    Time frame: 3 month follow-up

    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. General patient-, disease-, and treatment-related information

    Time frame: 6 month follow-up

    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).

  4. General patient-, disease-, and treatment-related information

    Time frame: 9 month follow-up

    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).

  5. General patient-, disease-, and treatment-related information

    Time frame: 12 month follow-up

    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. Appearance and date of local and regional recurrence

    Time frame: 12 month follow-up

    The possible appearance and date of local and/or regional recurrence will be collected.

  7. Appearance and date of local and regional recurrence

    Time frame: 2 years follow up

    The possible appearance and date of local and/or regional recurrence will be collected.

  8. Appearance and date of local and regional recurrence

    Time frame: 3 years follow up

    The possible appearance and date of local and/or regional recurrence will be collected.

  9. Appearance and date of local and regional recurrence

    Time frame: 4 years follow up

    The possible appearance and date of local and/or regional recurrence will be collected.

  10. Appearance and date of local and regional recurrence

    Time frame: 5 years follow up

    The possible appearance and date of local and/or regional recurrence will be collected.

  11. Appearance and date of secondary tumors

    Time frame: 1 year follow up

    The possible appearance and date of secondary tumors will be collected.

  12. Appearance and date of secondary tumors

    Time frame: 2 years follow up

    The possible appearance and date of secondary tumors will be collected.

  13. Appearance and date of secondary tumors

    Time frame: 3 years follow up

    The possible appearance and date of secondary tumors will be collected.

  14. Appearance and date of secondary tumors

    Time frame: 4 years follow up

    The possible appearance and date of secondary tumors will be collected.

  15. Appearance and date of secondary tumors

    Time frame: 5 years follow up

    The possible appearance and date of secondary tumors will be collected.

  16. Appearance and date of distant metastasis

    Time frame: 1 year follow up

    The possible appearance and date of distant metastasis will be collected.

  17. Appearance and date of distant metastasis

    Time frame: 2 years follow up

    The possible appearance and date of distant metastasis will be collected.

  18. Appearance and date of distant metastasis

    Time frame: 3 years follow up

    The possible appearance and date of distant metastasis will be collected.

  19. Appearance and date of distant metastasis

    Time frame: 4 years follow up

    The possible appearance and date of distant metastasis will be collected.

  20. Appearance and date of distant metastasis

    Time frame: 5 years follow up

    The possible appearance and date of distant metastasis will be collected.

  21. Date of death of any cause

    Time frame: 1 year follow up

    If the patient dies within the first year after the treatment, their date of death will be collected.

  22. Date of death of any cause

    Time frame: 2 years follow up

    If the patient dies within 2 years after the treatment, their date of death will be collected.

  23. Date of death of any cause

    Time frame: 3 years post treatment

    If the patient dies within 3 years after the treatment, their date of death will be collected.

  24. Date of death of any cause

    Time frame: 4 years follow up

    If the patient dies within 4 years after the treatment, their date of death will be collected.

  25. Date of death of any cause

    Time frame: 5 years follow up

    If the patient dies within 5 years after the treatment, their date of death will be collected.

Study contacts

Contact information is provided by the study sponsor or research team.

Jolien Robijns, PhD

CONTACT

[email protected]

011337229

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Collaborators

  • Hasselt University

Registry information

Official study title

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

Acronym: LymphLight

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Dec 30, 2020
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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