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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: November 30, 2015
Last verified: November 2015

February 26, 2009
November 30, 2015
September 2009
April 2012   (final data collection date for primary outcome measure)
  • 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.
Arm volume change [ Time Frame: Bioeipedance before each treatments and arm circumferences weekly. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00852930 on ClinicalTrials.gov Archive Site
  • 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.
  • Symptoms [ Time Frame: after treatment ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: after treatment ] [ Designated as safety issue: No ]
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.
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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphedema
  • 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
  • Experimental: laser alone
    The intervention was therapist administered low level laser therapy using low level laser, number of sessions based upon patient response
    Intervention: Procedure: laser alone
  • Active Comparator: mld alone
    The intervention was therapist administered manual lymphatic drainage (mld) using standard massage techniques,number of sessions based upon patient response
    Intervention: Procedure: 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
    Intervention: Procedure: laser and MLD combined
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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00852930
090118
No
Not Provided
Not Provided
Sheila H. Ridner, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: sheila h ridner, phd Vanderbilt Univeristy
Vanderbilt University
November 2015

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