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Low Level Laser Treatment and Breast Cancer Related Lymphedema

NCT00852930 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-04-11

Study results available
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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.

Conditions

  • Lymphedema

Interventions

PROCEDURE

laser and MLD combined

The intervention is therapist administered laser and mld treatment combined

PROCEDURE

laser alone

The intervention is therapist administered laser

PROCEDURE

manual lymphatic drainage

The intervention is therapist administered manual lymphatic drainage

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • sheila h ridner, phd · Vanderbilt Univeristy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00852930 on ClinicalTrials.gov