LLLT Combined With CDT in Breast Cancer-Related Lymphedema
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ClinicalTrials.gov Identifier: NCT01351376 |
Recruitment Status
:
Completed
First Posted
: May 10, 2011
Last Update Posted
: September 12, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer Lymphedema | Device: Low Level Laser Therapy Device: Low Level Laser | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | The Effectiveness of Low Level Laser Therapy (LLLT)Combined With Complex Decongestive Therapy (CDT) in the Treatment of Breast Cancer-Related Lymphedema: A Double-Blind, Randomized, Placebo-Controlled Study |
Study Start Date : | May 2011 |
Actual Primary Completion Date : | June 2016 |
Actual Study Completion Date : | July 2017 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
CDT + inactive LLL
|
Device: Low Level Laser Therapy
Placebo LLL combined with CDT
Other Names:
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Active Comparator: LLL combined with CDT
CDT + active LLL
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Device: Low Level Laser
Active LLL combined with CDT
Other Name: Complex Decongestive Therapy
|
- Arm Volume [ Time Frame: 5-6 measurements over the course of 13-14 months ]
- Quality of Life [ Time Frame: 5-6 measurements over a course of 12-13 months ]

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Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351376
United States, New York | |
NYU Clinical Cancer Center | |
New York, New York, United States, 10016 | |
NYU Rusk Institute of Rehabilitation Medicine | |
New York, New York, United States, 10016 | |
Tisch Hospital | |
New York, New York, United States, 10016 |
Principal Investigator: | Teresa Denham, PT, MA | NYU Rusk Institute of Rehabilitation Medicine |
Responsible Party: | New York University School of Medicine |
ClinicalTrials.gov Identifier: | NCT01351376 History of Changes |
Other Study ID Numbers: |
10-00923 |
First Posted: | May 10, 2011 Key Record Dates |
Last Update Posted: | September 12, 2017 |
Last Verified: | September 2017 |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | Yes | |
Device Product Not Approved or Cleared by U.S. FDA: | No | |
Pediatric Postmarket Surveillance of a Device Product: | No |
Keywords provided by New York University School of Medicine:
Lymphedema, Low Level Laser, Breast Cancer |
Additional relevant MeSH terms:
Breast Neoplasms Lymphedema Breast Cancer Lymphedema Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Lymphatic Diseases Postoperative Complications Pathologic Processes |