CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
laser and MLD combined +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00852930
NCT00852930Phase 4Completed

Low Level Laser Treatment and Breast Cancer Related Lymphedema

Vanderbilt University·interventional·Posted Feb 27, 2009·Updated Apr 11, 2017

In Brief

A Phase 4 clinical trial evaluating laser and MLD combined, laser alone, and 1 other intervention for Lymphedema. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphedema
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 27, 2009
Enrollment StartSep 1, 2009
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 17.3 years ago

Interventions

laser and MLD combinedprocedure

The intervention is therapist administered laser and mld treatment combined

laser aloneprocedure

The intervention is therapist administered laser

manual lymphatic drainageprocedure

The intervention is therapist administered manual lymphatic drainage