LLLT Combined With CDT in Breast Cancer-Related Lymphedema

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351376
• Other study ID #: 10-00923
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: July 2017

Study information

• Verified date: September 2019
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema

Intervention

Device:
• Low Level Laser Therapy
Placebo LLL combined with CDT
• Low Level Laser
Active LLL combined with CDT

Locations

Country	Name	City	State
United States	NYU Clinical Cancer Center	New York	New York
United States	NYU Rusk Institute of Rehabilitation Medicine	New York	New York
United States	Tisch Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arm Volume		13 Months
Secondary	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