LLLT Combined With CDT in Breast Cancer-Related Lymphedema

NYU Langone Health

Status: Completed

Conditions: Breast Cancer; Lymphedema

Treatments: Device: Low Level Laser; Device: Low Level Laser Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01351376

10-00923

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

CDT + inactive LLL

Treatment:

Device: Low Level Laser Therapy

LLL combined with CDT

Active Comparator group

Description:

CDT + active LLL

Treatment:

Device: Low Level Laser