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Trial record 12 of 18 for:    mebis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04690439
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : March 8, 2022
Sponsor:
Collaborator:
Hasselt University
Information provided by (Responsible Party):
Jessa Hospital

Brief Summary:
Up to one out of five patients with breast cancer will develop lymphedema in the upper extremity after cancer treatment. Patients with breast cancer-related lymphedema (BCRL) suffer from pain, heaviness, tightness, and a decreased range of motion. Photobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and/or near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. Therefore, the aim of this study is to evaluate the effectiveness of PBMT on the management of BCRL.

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Cancer Related Lymphedema Lymphedema of Upper Arm Device: Photobiomodulation therapy (PBMT) Procedure: Manual Lymphatic drainage Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective randomized, controlled cross-over trial
Masking: Single (Outcomes Assessor)
Masking Description: Single : outcome assessor
Primary Purpose: Treatment
Official Title: Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Breast Cancer-Related Lymphedema: a Randomized Controlled Trial
Actual Study Start Date : February 22, 2021
Estimated Primary Completion Date : February 2028
Estimated Study Completion Date : February 2028

Resource links provided by the National Library of Medicine


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 Name: LLLT

Procedure: Manual Lymphatic drainage
Patients will receive twice weekly MLT executed by trained physiotherapist
Other Name: 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 Name: LLLT

Procedure: Manual Lymphatic drainage
Patients will receive twice weekly MLT executed by trained physiotherapist
Other Name: MLT




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with breast cancer
  • Underwent ipsilateral lumpectomy or mastectomy + sentinel lymph node biopsy +/- lymph node dissection
  • Underwent radiotherapy with or without chemotherapy
  • Diagnosed with BCRL (i.e. International Society of Lymphology (ISL) lymphedema stage I or higher)
  • Age ≥ 18 years
  • Able to comply to the study protocol
  • Able to sign written informed consent

Exclusion Criteria:

  • Metastatic disease
  • Pregnancy
  • History of surgery or trauma to the arm
  • History of arm infection in the past 3 months
  • Use of medications that affect body fluid (e.g., diuretics) in the last 3 months
  • Severe psychological disorder or dementia
  • Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04690439


Contacts
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Contact: Jolien Robijns, PhD 011337229 jolien.robijns@jessazh.be

Locations
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Belgium
Hasselt University Recruiting
Hasselt, Limburg, Belgium, 3500
Contact: Jolien Robijns, PhD       jolien.robijns@uhasselt.be   
Principal Investigator: Jeroen Mebis, MD, PhD         
Sub-Investigator: Joy Lodewijckx, MSc         
Jessa Ziekenhuis Recruiting
Hasselt, Limburg, Belgium, 3500
Contact: Jolien Robijns, PhD         
Principal Investigator: Jeroen Mebis, MD, PhD         
Sub-Investigator: Joy Lodewijckx, MSc         
Sponsors and Collaborators
Jessa Hospital
Hasselt University
Investigators
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Principal Investigator: Jeroen Mebis, MD, PhD Jessa Hospital
Additional Information:
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Responsible Party: Jessa Hospital
ClinicalTrials.gov Identifier: NCT04690439    
Other Study ID Numbers: 2020-154
B2342020000029 ( Registry Identifier: Belgian Registry )
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: March 8, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Jessa Hospital:
Lymphedema
Breast cancer
Photobiomodulation
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Postoperative Complications
Pathologic Processes