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.

Study Overview

• Status: Completed
• Conditions: Lymphedema
• Intervention / Treatment: Procedure: laser alone; Procedure: manual lymphatic drainage; Procedure: laser and MLD 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37240
      • Vanderbilt University School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDex Change-	Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.	Bioimpedance at baseline and end of treatment with the average number of treaments being 9 conducted over a median of up to 4 weeks.
Whole Arm Volume Difference	Whole arm measurement to determine volume.	Baseline and on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms	Yes/no response to a symptom listed on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A) self-report form.	Self report on last day of treatment with average treatments being 9 conducted over a median of up to 4 weeks.
Quality of Life	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.	Self-report on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: sheila h ridner, phd, Vanderbilt Univeristy

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: February 26, 2009
• First Submitted That Met QC Criteria: February 26, 2009
• First Posted (Estimate): February 27, 2009

Study Record Updates

• Last Update Posted (Actual): April 11, 2017
• Last Update Submitted That Met QC Criteria: April 7, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: breast cancer; quality of life; symptoms; lymphedema; lymphedema in breast cancer survivors
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: 090118