LLLT Combined With CDT in Breast Cancer-Related Lymphedema

Completed · Not applicable · Has a placebo group

Conditions studied: Breast Cancer, Lymphedema

In brief

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.

Key facts

Study ID

NCT01351376

Run by

NYU Langone Health

People needed

21

Starts

2011-05-01

Expected to finish

2017-07-01

Last updated by the study team

2019-09-19

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• NYU Clinical Cancer Center — New York, New York, United States
• NYU Rusk Institute of Rehabilitation Medicine — New York, New York, United States
• Tisch Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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