Low Level Laser Treatment and Breast Cancer Related Lymphedema

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sheila H. Ridner, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00852930

First received: February 26, 2009

Last updated: December 18, 2012

Last verified: December 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 26, 2009
Last Updated Date	December 18, 2012
Start Date ^ICMJE	September 2009
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 26, 2009)	Arm volume change [ Time Frame: Bioeipedance before each treatments and arm circumferences weekly. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00852930 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 26, 2009)	symptoms [ Time Frame: after treatment ] [ Designated as safety issue: Yes ] quality of life [ Time Frame: after treatment ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Low Level Laser Treatment and Breast Cancer Related Lymphedema
Official Title ^ICMJE	Low Level Laser Treatment and Breast Cancer Related Lymphedema
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Lymphedema
Intervention ^ICMJE	Procedure: Low Level Laser Therapy with Manual Lymphatic Drainage therapist will give both mld and laser treatment Procedure: laser therapist administered laser Procedure: manual lymphatic drainage therapist administered massage therapy
Study Arm (s)	Experimental: laser therapy alone therapist administered laser treatment Intervention: Procedure: laser Active Comparator: mld alone therapist administered manual lymphatic drainage Intervention: Procedure: manual lymphatic drainage Experimental: laser and mld combined therapist administered laser and mld Intervention: Procedure: Low Level Laser Therapy with Manual Lymphatic Drainage
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	50
Completion Date	April 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	21 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00852930
Other Study ID Numbers ^ICMJE	090118
Has Data Monitoring Committee	No
Responsible Party	Sheila H. Ridner, Vanderbilt University
Study Sponsor ^ICMJE	Vanderbilt University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Vanderbilt University
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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