N/A N=21 Randomized Double-blind Treatment

LLLT Combined With CDT in Breast Cancer-Related Lymphedema

Breast Cancer · Lymphedema

Bottom Line

View on ClinicalTrials.gov: NCT01351376 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2019

Primary outcome: Primary: Arm Volume — 1.48; 1.58 cm^3

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Low Level Laser Therapy (Device); Low Level Laser (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: Female
Sponsor: NYU Langone Health
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Arm Volume	1.48; 1.58	—
SECONDARY Short-Form Health Survey (SF-36)	75.5085; 72.6042	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01351376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.