Low Level Laser Treatment and Breast Cancer Related Lymphedema

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Low Level Laser Treatment and Breast Cancer Related Lymphedema

Conditions
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Lymphedema

Intervention / Treatment
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* Procedure: laser and MLD combined
* Procedure: laser alone
* Procedure: manual lymphatic drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast cancer survivors will be included if they: are age 21 or older; require professional treatment for Stage I or II lymphedema as defined by the International Society of Lymphology; have an order for lymphedema treatment; and are willing and able to drive to the study sites. Exclusion Criteria: Individuals will not be included if they: are actively undergoing intravenous chemotherapy or radiation therapy; have a history of bilateral lymphedema that prohibits extracellular fluid comparison to an unaffected limb; are unable to stand upright for measurement of height and weight; have active/metastatic cancer; are pregnant,: have artificial joints in areas where electrode placement is critical, or have a pacemaker/internal defibrillator; or 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laser alone<br>The intervention was therapist administered low level laser therapy using low level laser, number of sessions based upon patient response | Procedure: laser alone<br>* The intervention is therapist administered laser<br>|
| Active Comparator: mld alone<br>The intervention was therapist administered manual lymphatic drainage (mld) using standard massage techniques,number of sessions based upon patient response | Procedure: manual lymphatic drainage<br>* The intervention is therapist administered manual lymphatic drainage<br>|
| Experimental: laser and mld combined<br>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<br>* The intervention is therapist administered laser and mld treatment combined<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphedema, quality of life, breast cancer, symptoms, lymphedema in breast cancer survivors