Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJessa Hospital
About this trial
Up to one out of five patients with breast cancer will develop lymphedema in the upper extremity after cancer treatment. Patients with breast cancer-related lymphedema (BCRL) suffer from pain, heaviness, tightness, and a decreased range of motion. Photobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and/or near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. Therefore, the aim of this study is to evaluate the effectiveness of PBMT on the management of BCRL.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Metastatic disease
Pregnancy
History of surgery or trauma to the arm
History of arm infection in the past 3 months
Trial design
Design model
Parallel
Treatments tested in this trial
Photobiomodulation therapy (PBMT)
DeviceThe MLS M6 laser from ASA will be used to apply the laser therapy.
Manual Lymphatic drainage
Procedure/SurgeryPatients will receive twice weekly MLT executed by trained physiotherapist
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: Group AExperimental treatment 2 interventions
Group B: Group BActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Arm circumference and volume
The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 \* (C1\* C1 +C1\*C2+C2\*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter
Time frame
Baseline2
Arm circumference and volume
The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 \* (C1\* C1 +C1\*C2+C2\*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter
Time frame
week 53
Arm circumference and volume
The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 \* (C1\* C1 +C1\*C2+C2\*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter
Time frame
week 94
Arm circumference and volume
The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 \* (C1\* C1 +C1\*C2+C2\*C2)/12π C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter
Time frame
Week 14Secondary outcomes
1
Pain assessment
The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony).
Time frame
Baseline2
Pain assessment
The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony).
Time frame
week 53
Pain assessment
The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony).
Time frame
week 94
Pain assessment
The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony).
Time frame
week 14Other outcomes
1
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).
Time frame
Baseline2
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).
Time frame
3 month follow-up3
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).
Time frame
6 month follow-up4
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).
Time frame
9 month follow-upSponsors and contacts
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Jessa Hospital
Lead sponsor
Hasselt University
Collaborator
Source ClinicalTrials.gov