LLLT Combined With CDT in Breast Cancer-Related Lymphedema

Not Applicable

Completed

• Conditions: Breast Cancer; Lymphedema
• Interventions: Device: Low Level Laser; Device: Low Level Laser Therapy

• Registration Number: NCT01351376
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-05-09
• Study First Posted: 2011-05-10
• Primary Completion: 2016-06
• Study Completion: 2017-07
• Results First Submitted: 2017-12-05
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-18
• Last Update Submitted: 2019-09-18
• Results First Posted: 2019-09-19
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LLL combined with CDT	Low Level Laser	CDT + active LLL
Placebo	Low Level Laser Therapy	CDT + inactive LLL

Primary Outcome Measures

Name	Time	Method
Arm Volume	13 Months

Secondary Outcome Measures

Name	Time	Method
Short-Form Health Survey (SF-36)	13 months	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.

Trial Locations

Locations (3)

NYU Rusk Institute of Rehabilitation Medicine; 🇺🇸 New York, New York, United States

Tisch Hospital; 🇺🇸 New York, New York, United States

NYU Clinical Cancer Center; 🇺🇸 New York, New York, United States