Breast Cancer, Lymphedema
Conditions
Keywords
Lymphedema, Low Level Laser, Breast Cancer
Brief summary
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.
Interventions
DEVICELow Level Laser Therapy
Placebo LLL combined with CDT
DEVICELow Level Laser
Active LLL combined with CDT
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Arm Volume | 13 Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-Form Health Survey (SF-36) | 13 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo CDT + inactive LLL
Low Level Laser Therapy: Placebo LLL combined with CDT | 10 |
| LLL Combined With CDT CDT + active LLL
Low Level Laser: Active LLL combined with CDT | 11 |
| Total | 21 |
Baseline characteristics
| Characteristic | Placebo | LLL Combined With CDT | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 11 Participants | 21 Participants |
| Region of Enrollment United States | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 0 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 11 |
Outcome results
Primary
Arm Volume
Time frame: 13 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Arm Volume | 1.48 cm^3 | Standard Deviation 1.01 |
| LLL Combined With CDT | Arm Volume | 1.58 cm^3 | Standard Deviation 1 |
Secondary
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.
Time frame: 13 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Short-Form Health Survey (SF-36) | 75.5085 score on a scale | Standard Deviation 16.07351 |
| LLL Combined With CDT | Short-Form Health Survey (SF-36) | 72.6042 score on a scale | Standard Deviation 18.01269 |