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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
  Purpose

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.


Condition Intervention Phase
Lymphedema
 Procedure: Low Level Laser Therapy with Manual Lymphatic Drainage
Procedure: laser
Procedure: manual lymphatic drainage
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low Level Laser Treatment and Breast Cancer Related Lymphedema

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Arm volume change [ Time Frame: Bioeipedance before each treatments and arm circumferences weekly. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • symptoms [ Time Frame: after treatment ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: after treatment ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: September 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: laser therapy alone
therapist administered laser treatment
 Procedure: laser
therapist administered laser
Active Comparator: mld alone
therapist administered manual lymphatic drainage
 Procedure: manual lymphatic drainage
therapist administered massage therapy
Experimental: laser and mld combined
therapist administered laser and mld
 Procedure: Low Level Laser Therapy with Manual Lymphatic Drainage
therapist will give both mld and laser treatment

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852930

Locations
United States, Tennessee
Vanderbilt University School of Nursing
Nashville, Tennessee, United States, 37240
Sponsors and Collaborators
Vanderbilt University
  More Information

No publications provided

Responsible Party: Sheila H. Ridner, professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00852930     History of Changes
Other Study ID Numbers: 090118
Study First Received: February 26, 2009
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
lymphedema
quality of life
breast cancer
symptoms
lymphedema in breast cancer survivors

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Lymphatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013