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 quality of life when compared to the benefits of CDT alone for the treatment of breast cancer-related lymphedema.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Lymphedema
• Intervention / Treatment: Device: Low Level Laser Therapy; Device: Low Level Laser

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Clinical Cancer Center
    • New York, New York, United States, 10016
      • Tisch Hospital
    • New York, New York, United States, 10016
      • NYU Rusk Institute of Rehabilitation Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Complex Decongestive Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Arm Volume	13 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	13 months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Teresa Denham, PT, MA, NYU Rusk Institute of Rehabilitation Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: May 9, 2011
• First Submitted That Met QC Criteria: May 9, 2011
• First Posted (Estimate): May 10, 2011

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Lymphedema, Low Level Laser, Breast Cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: 10-00923

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes