Low Level Laser Treatment and Breast Cancer Related Lymphedema

Lymphedema Clinical Trial

Official title:

Low Level Laser Treatment and Breast Cancer Related Lymphedema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852930
• Other study ID #: 090118
• Status: Completed
• Phase: Phase 4
• First received: February 26, 2009
• Last updated: April 7, 2017
• Start date: September 2009
• Est. completion date: April 2012

Study information

• Verified date: April 2017
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Lymphedema

Intervention

Procedure:
• laser and MLD combined
The intervention is therapist administered laser and mld treatment combined
• laser alone
The intervention is therapist administered laser
• manual lymphatic drainage
The intervention is therapist administered manual lymphatic drainage

Locations

Country	Name	City	State
United States	Vanderbilt University School of Nursing	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.