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

February 26, 2009
December 18, 2012
September 2009
April 2012   (final data collection date for primary outcome measure)
Arm volume change [ Time Frame: Bioeipedance before each treatments and arm circumferences weekly. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00852930 on ClinicalTrials.gov Archive Site
  • symptoms [ Time Frame: after treatment ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: after treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Low Level Laser Treatment and Breast Cancer Related Lymphedema
Low Level Laser Treatment and Breast Cancer Related Lymphedema

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphedema
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

Breast cancer survivors will be included if they:

  1. are age 21 or older;
  2. require professional treatment for Stage I or II lymphedema as defined by the International Society of Lymphology;
  3. have an order for lymphedema treatment; and
  4. are willing and able to drive to the study sites.

Exclusion Criteria:

Individuals will not be included if they:

  1. are actively undergoing intravenous chemotherapy or radiation therapy;
  2. have a history of bilateral lymphedema that prohibits extracellular fluid comparison to an unaffected limb;
  3. are unable to stand upright for measurement of height and weight;
  4. have active/metastatic cancer;
  5. are pregnant,:
  6. have artificial joints in areas where electrode placement is critical, or have a pacemaker/internal defibrillator; or
  7. 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.
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00852930
090118
No
Sheila H. Ridner, Vanderbilt University
Vanderbilt University
Not Provided
Not Provided
Vanderbilt University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP