LLLT Combined With CDT in Breast Cancer-Related Lymphedema
NCT ID: NCT01351376
Last Updated: 2019-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2011-05-31
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
CDT + inactive LLL
Low Level Laser Therapy
Placebo LLL combined with CDT
LLL combined with CDT
CDT + active LLL
Low Level Laser
Active LLL combined with CDT
Interventions
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Low Level Laser Therapy
Placebo LLL combined with CDT
Low Level Laser
Active LLL combined with CDT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
21 Years
FEMALE
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Teresa Denham, PT, MA
Role: PRINCIPAL_INVESTIGATOR
NYU Rusk Institute of Rehabilitation Medicine
Locations
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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
Countries
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Other Identifiers
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10-00923
Identifier Type: -
Identifier Source: org_study_id
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