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LLLT Combined With CDT in Breast Cancer-Related Lymphedema
This study has been completed.
Sponsor:
New York University School of Medicine
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01351376
First received: May 9, 2011
Last updated: July 7, 2016
Last verified: July 2016
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Purpose
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 girth, pain levels, tissue texture, symptoms experienced, and quality of life when compared to the benefits of CDT alone for the treatment of breast cancer-related lymphedema.
| Condition | Intervention |
|---|---|
| Breast Cancer Lymphedema | Device: Low Level Laser Therapy Device: Low Level Laser |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
Further study details as provided by New York University School of Medicine:
Primary Outcome Measures:
- Arm Volume [ Time Frame: 5-6 measurements over the course of 13-14 months ]
Secondary Outcome Measures:
- Quality of Life [ Time Frame: 5-6 measurements over a course of 12-13 months ]
| Enrollment: | 150 |
| Study Start Date: | May 2011 |
| Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
CDT + inactive LLL
|
Device: Low Level Laser Therapy
Placebo LLL combined with CDT
Other Names:
|
|
Active Comparator: LLL combined with CDT
CDT + active LLL
|
Device: Low Level Laser
Active LLL combined with CDT
Other Name: Complex Decongestive Therapy
|
Eligibility| Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01351376
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351376
Locations
| 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 | |
Sponsors and Collaborators
New York University School of Medicine
Investigators
| Principal Investigator: | Teresa Denham, PT, MA | NYU Rusk Institute of Rehabilitation Medicine |
More Information
| Responsible Party: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01351376 History of Changes |
| Other Study ID Numbers: |
10-00923 |
| Study First Received: | May 9, 2011 |
| Last Updated: | July 7, 2016 |
Keywords provided by New York University School of Medicine:
|
Lymphedema, Low Level Laser, Breast Cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Lymphedema Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Lymphatic Diseases |
ClinicalTrials.gov processed this record on June 28, 2017