Breast Cancer, Breast Cancer Related Lymphedema, Lymphedema of Upper Arm
Conditions
Keywords
Lymphedema, Breast cancer, Photobiomodulation
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.
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.
Interventions
The MLS M6 laser from ASA will be used to apply the laser therapy.
PROCEDUREManual Lymphatic drainage
Patients will receive twice weekly MLT executed by trained physiotherapist
Sponsors
Hasselt University
Jessa Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single : outcome assessor
Intervention model description
prospective randomized, controlled cross-over trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arm circumference and volume | 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 |
| ISL classification | Baseline | The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician. |
| Activity and participation | 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. |
| Arm mobility measurement | Baseline | A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessment | 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). |
| Pain assessment | 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). |
| Depression, anxiety and stress | 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. |
| Patients' satisfaction with the therapeutic intervention | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Appearance and date of local and regional recurrence | 12 month follow-up | The possible appearance and date of local and/or regional recurrence will be collected. |
| Date of death of any cause | 1 year follow up | If the patient dies within the first year after the treatment, their date of death will be collected. |
| Appearance and date of distant metastasis | 1 year follow up | The possible appearance and date of distant metastasis will be collected. |
| General patient-, disease-, and treatment-related information | 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). |
| Appearance and date of secondary tumors | 1 year follow up | The possible appearance and date of secondary tumors will be collected. |
Countries
Belgium
Contacts
Primary ContactJolien Robijns, PhD
Outcome results
None listed