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: November 30, 2015
Last verified: November 2015
  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: laser and MLD combined
Procedure: laser alone
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:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • LDex Change- [ Time Frame: Bioimpedance at baseline and end of treatment with the average number of treaments being 9 conducted over a median of up to 4 weeks. ] [ Designated as safety issue: No ]
    Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.

  • Whole Arm Volume Difference [ Time Frame: Baseline and on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks. ] [ Designated as safety issue: No ]
    Whole arm measurement to determine volume.


Secondary Outcome Measures:
  • Symptoms [ Time Frame: Self report on last day of treatment with average treatments being 9 conducted over a median of up to 4 weeks. ] [ Designated as safety issue: Yes ]
    Yes/no response to a symptom listed on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A) self-report form.

  • Quality of Life [ Time Frame: Self-report on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks. ] [ Designated as safety issue: No ]
    The Functional Assessment of Chronic Illness Therapy that measure quality of life -total score. Range of scores could be 0 to 148. Higher score represents higher quality of life.


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 alone
The intervention was therapist administered low level laser therapy using low level laser, number of sessions based upon patient response
Procedure: laser alone
The intervention is therapist administered laser
Active Comparator: mld alone
The intervention was therapist administered manual lymphatic drainage (mld) using standard massage techniques,number of sessions based upon patient response
Procedure: manual lymphatic drainage
The intervention is therapist administered manual lymphatic drainage
Experimental: laser and mld combined
The intervention was therapist administered low level laser and mld using low level laser and standard massage techniques, number of sessions based upon patient response
Procedure: laser and MLD combined
The intervention is therapist administered laser and mld treatment combined

Detailed Description:
The purpose 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 related LE. Findings from this pilot randomized study will be used to determine if LLLT has possible value in the treatment of LE and warrants subsequent evaluation in a larger study.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: sheila h ridner, phd Vanderbilt Univeristy
  More Information

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
Results First Received: July 17, 2015
Last Updated: November 30, 2015
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
Breast Diseases
Lymphatic Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on May 01, 2016