Low Level Laser Treatment and Breast Cancer Related Lymphedema

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2012

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.

Interventions

  • 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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary 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.
    • 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.
    • Whole arm measurement to determine volume.

Secondary 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.
    • 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.
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sheila Ridner, professor – Vanderbilt University
  • Overall Official(s)
    • sheila h ridner, phd, Principal Investigator, Vanderbilt Univeristy

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