Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

LLLT Combined With CDT in Breast Cancer-Related Lymphedema

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by New York University School of Medicine
Sponsor:
Collaborator:
Hunter College
Information provided by (Responsible Party):
Tara Denham, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01351376
First received: May 9, 2011
Last updated: August 26, 2014
Last verified: August 2014
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 5-6 measurements over a course of 12-13 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 150
Study Start Date: May 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (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:
  • 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 Names:
  • Low Level Laser
  • Complex Decongestive Therapy

  Eligibility
Ages Eligible for Study:   21 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351376

Contacts
Contact: Teresa Denham, PT, MA 212-263-8466 tara.denham@nyumc.org

Locations
United States, New York
NYU Clinical Cancer Center Recruiting
New York, New York, United States, 10016
Contact: Teresa Denham, PT, MA    212-263-8466      
NYU Rusk Institute of Rehabilitation Medicine Recruiting
New York, New York, United States, 10016
Contact: Teresa Denham, PT, MA    212-263-8466    tara.denham@nyumc.org   
Principal Investigator: Teresa Denham, PT, MA         
Tisch Hospital Recruiting
New York, New York, United States, 10016
Contact: Teresa Denham, PT, MA         
Sponsors and Collaborators
New York University School of Medicine
Hunter College
Investigators
Principal Investigator: Teresa Denham, PT, MA NYU Rusk Institute of Rehabilitation Medicine
  More Information

No publications provided

Responsible Party: Tara Denham, Outpatient Program Manger Physical Therapy, 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: August 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Lymphedema, Low Level Laser, Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Breast Diseases
Lymphatic Diseases
 Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on March 03, 2015