Breast Cancer Clinical Trial

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LLLT Combined With CDT in Breast Cancer-Related Lymphedema

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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.

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Eligibility Criteria

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)

Study is for people with:

Breast Cancer

Estimated Enrollment:

21

Study ID:

NCT01351376

Recruitment Status:

Completed

Sponsor:

NYU Langone Health

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There is 1 Location for this study

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NYU Clinical Cancer Center
New York New York, 10016, United States
NYU Rusk Institute of Rehabilitation Medicine
New York New York, 10016, United States
Tisch Hospital
New York New York, 10016, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

21

Study ID:

NCT01351376

Recruitment Status:

Completed

Sponsor:


NYU Langone Health

How clear is this clinincal trial information?

Clinical Trial Resources

SurvivorNet’s Guide To Clinical Trials: What Are They And Are They Right for You?
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