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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
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

Study Description
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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 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 or disease Intervention/treatment Phase
Breast Cancer Lymphedema Device: Low Level Laser Therapy Device: Low Level Laser Not Applicable

Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
CDT + inactive LLL
 Device: Low Level Laser Therapy
Placebo LLL combined with CDT
Other Names:
  • Low Level Laser
  • Complex Decongestive Therapy
Active Comparator: LLL combined with CDT
CDT + active LLL
 Device: Low Level Laser
Active LLL combined with CDT
Other Name: Complex Decongestive Therapy


Outcome Measures
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Primary Outcome Measures :
  1. Arm Volume [ Time Frame: 5-6 measurements over the course of 13-14 months ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 5-6 measurements over a course of 12-13 months ]

Eligibility Criteria
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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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