Phase 4
Completed N=50
Low Level Laser Treatment and Breast Cancer Related Lymphedema
Source: ClinicalTrials.gov NCT00852930 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcomePrimary: LDex Change- — 28.0; 17.8; 22.2 LDex
Summary
Manual Lymphatic Drainage (massage therapy) with compression (wearing a tight sleeve on the arm) is the current standard of treatment for breast cancer related lymphedema (arm swelling). Low-Level Laser Therapy (LLLT) was approved in 2006 by the FDA for professional and self/home treatment of lymphedema. LLLT is being offered as a treatment option in many lymphedema treatment settings, but there are few studies of the effectiveness of LLLT as a stand-alone lymphedema treatment or as a possible complementary lymphedema treatment modality to Manual Lymphatic Drainage. The objective of this proposed pilot study is to examine the impact of Advance Practice Nurse (ANP) administered LLLT, as both a stand-alone and complementary treatment, on arm volume, symptoms, and quality of life (QOL) in breast cancer survivors with lymphedema. Findings from this pilot study will be used to determine if LLLT has possible value in the treatment of lymphedema and warrants subsequent evaluation in a larger study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY LDex Change- |
28.0; 17.8; 22.2 | — |
| PRIMARY Whole Arm Volume Difference |
15.0; 6.8; 13.4 | — |
| SECONDARY Symptoms |
12; 12.5; 14 | — |
| SECONDARY Quality of Life |
113.5; 116.25; 110 | — |
Eligibility Criteria
Inclusion Criteria
Breast cancer survivors will be included if they:
- are age 21 or older;
- require professional treatment for Stage I or II lymphedema as defined by the International Society of Lymphology;
- have an order for lymphedema treatment; and
- are willing and able to drive to the study sites.
Exclusion Criteria
Individuals will not be included if they:
- are actively undergoing intravenous chemotherapy or radiation therapy;
- have a history of bilateral lymphedema that prohibits extracellular fluid comparison to an unaffected limb;
- are unable to stand upright for measurement of height and weight;
- have active/metastatic cancer;
- are pregnant,:
- have artificial joints in areas where electrode placement is critical, or have a pacemaker/internal defibrillator; or
- have congestive heart failure (CHF), chronic/acute renal or hepatic disease, pulmonary edema, thrombophlebitis, deep vein thrombosis (DVT), acute infection of any kind, and inflammation in the trunk or arms.
Data sourced from ClinicalTrials.gov (NCT00852930). 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. Informational only — not medical advice.