LLLT Combined With CDT in Breast Cancer-Related Lymphedema

This study has been completed.
Sponsor:
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

May 9, 2011
July 7, 2016
May 2011
June 2016   (final data collection date for primary outcome measure)
Arm Volume [ Time Frame: 5-6 measurements over the course of 13-14 months ] [ Designated as safety issue: No ]
Circumferential measurements [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
The measurements will be conducted on both affected and non-affected limbs at the hand proximal to the metacarpals, wrist, and then every 4 cm from the wrist to axilla.
Complete list of historical versions of study NCT01351376 on ClinicalTrials.gov Archive Site
Quality of Life [ Time Frame: 5-6 measurements over a course of 12-13 months ] [ Designated as safety issue: No ]
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LLLT Combined With CDT in Breast Cancer-Related Lymphedema
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
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.
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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Breast Cancer
  • Lymphedema
  • Device: Low Level Laser Therapy
    Placebo LLL combined with CDT
    Other Names:
    • Low Level Laser
    • Complex Decongestive Therapy
  • Device: Low Level Laser
    Active LLL combined with CDT
    Other Name: Complex Decongestive Therapy
  • Placebo Comparator: Placebo
    CDT + inactive LLL
    Intervention: Device: Low Level Laser Therapy
  • Active Comparator: LLL combined with CDT
    CDT + active LLL
    Intervention: Device: Low Level Laser
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
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June 2016   (final data collection date for primary outcome measure)

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)
Female
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01351376
10-00923
No
Not Provided
Not Provided
New York University School of Medicine
New York University School of Medicine
Not Provided
Principal Investigator: Teresa Denham, PT, MA NYU Rusk Institute of Rehabilitation Medicine
New York University School of Medicine
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP