Back to resultsLLLT Combined With CDT in Breast Cancer-Related Lymphedema
Primary Purpose
Breast Cancer, Lymphedema
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Level Laser Therapy
Low Level Laser
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Lymphedema, Low Level Laser, Breast Cancer
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)
Sites / Locations
- NYU Clinical Cancer Center
- NYU Rusk Institute of Rehabilitation Medicine
- Tisch Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
LLL combined with CDT
Arm Description
CDT + inactive LLL
CDT + active LLL
Outcomes
Primary Outcome Measures
Arm Volume
Secondary Outcome Measures
Short-Form Health Survey (SF-36)
Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health. The individual question items (Likert scale 0-4) are first summed for each item under the various sections. Then, those summary scores are then standardized on a scale between 0 and 1 using the mean and standard deviation of the actual scores and finally, weighted to a scale between 0 and 100. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01351376
Brief Title
LLLT Combined With CDT in Breast Cancer-Related Lymphedema
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 Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lymphedema
Keywords
Lymphedema, Low Level Laser, Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
CDT + inactive LLL
Arm Title
LLL combined with CDT
Arm Type
Active Comparator
Arm Description
CDT + active LLL
Intervention Type
Device
Intervention Name(s)
Low Level Laser Therapy
Other Intervention Name(s)
Low Level Laser, Complex Decongestive Therapy
Intervention Description
Placebo LLL combined with CDT
Intervention Type
Device
Intervention Name(s)
Low Level Laser
Other Intervention Name(s)
Complex Decongestive Therapy
Intervention Description
Active LLL combined with CDT
Primary Outcome Measure Information:
Title
Arm Volume
Time Frame
13 Months
Secondary Outcome Measure Information:
Title
Short-Form Health Survey (SF-36)
Description
Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health. The individual question items (Likert scale 0-4) are first summed for each item under the various sections. Then, those summary scores are then standardized on a scale between 0 and 1 using the mean and standard deviation of the actual scores and finally, weighted to a scale between 0 and 100. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Time Frame
13 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Denham, PT, MA
Organizational Affiliation
NYU Rusk Institute of Rehabilitation Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Clinical Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Rusk Institute of Rehabilitation Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Tisch Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
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LLLT Combined With CDT in Breast Cancer-Related Lymphedema
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