LLLT Combined With CDT in Breast Cancer-Related Lymphedema

Study Overview
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Brief Summary
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This study aims to explore the effects of Low Level Laser Therapy (LLLT) on breast cancer-related lymphedema when utilized in conjunction with Complex Decongestive Therapy (CDT) when compared to CDT treatment alone. The investigators hypothesize that the addition of LLLT to CDT will result in statistically significant improvements and greater long-term benefits as measured by changes in arm volume and quality of life when compared to the benefits of CDT alone for the treatment of breast cancer-related lymphedema.

Official Title
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The Effectiveness of Low Level Laser Therapy (LLLT)Combined With Complex Decongestive Therapy (CDT) in the Treatment of Breast Cancer-Related Lymphedema: A Double-Blind, Randomized, Placebo-Controlled Study

Conditions
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Breast Cancer, Lymphedema

Intervention / Treatment
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* Device: Low Level Laser Therapy
* Device: Low Level Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral breast cancer with ipsilateral lumpectomy or mastectomy and lymph node dissection (sentinel biopsy or axillary dissection) stage II or III unilateral secondary upper extremity lymphedema (as defined by the International Society of Lymphology) girth ≥ 2 cm circumferential difference and/or volume ≥ 200 mL compared to the uninvolved upper extremity at any 4 cm segment able to commit to a long term follow-up schedule Exclusion Criteria: active cancer/metastatic cancer currently receiving or have plans for adjuvant radiation or chemotherapy pregnant presence of other extremity lymphedema (primary or secondary) pacemaker artificial joints in the upper quadrants renal failure arterial insufficiency congestive heart failure chronic inflammatory conditions history of deep vein thrombosis (DVT) in the lymphedematous upper extremity previous treatment with Low Level Laser (regardless of indication) medication(s) known to affect body fluid balance body mass index (BMI) > 40 (morbid obesity)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>CDT + inactive LLL | Device: Low Level Laser Therapy<br>* Placebo LLL combined with CDT<br>* Other names: Complex Decongestive Therapy;|
| Active Comparator: LLL combined with CDT<br>CDT + active LLL | Device: Low Level Laser<br>* Active LLL combined with CDT<br>* Other names: Complex Decongestive Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arm Volume |  | 13 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-Form Health Survey (SF-36) | Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health. The individual question items (Likert scale 0-4) are first summed for each item under the various sections. Then, those summary scores are then standardized on a scale between 0 and 1 using the mean and standard deviation of the actual scores and finally, weighted to a scale between 0 and 100. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. | 13 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphedema, Low Level Laser, Breast Cancer