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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


N/A
21 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Lymphedema

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Arm Volume

Outcome Time Frame:

5-6 measurements over the course of 13-14 months

Safety Issue:

No

Principal Investigator

Teresa Denham, PT, MA

Investigator Role:

Principal Investigator

Investigator Affiliation:

NYU Rusk Institute of Rehabilitation Medicine

Authority:

United States: Institutional Review Board

Study ID:

10-00923

NCT ID:

NCT01351376

Start Date:

May 2011

Completion Date:

May 2014

Related Keywords:

  • Breast Cancer
  • Lymphedema
  • Lymphedema, Low Level Laser, Breast Cancer
  • Breast Neoplasms
  • Lymphedema

Name

Location
NYU Clinical Cancer Center New York, New York  10016
Tisch Hospital New York, New York  10016
NYU Rusk Institute of Rehabilitation Medicine New York, New York  10016