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Low Level Laser Treatment and Breast Cancer Related Lymphedema

Primary Purpose

Lymphedema

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

laser and MLD combined

laser alone

manual lymphatic drainage

About this trial

This is an interventional treatment trial for Lymphedema focused on measuring lymphedema, quality of life, breast cancer, symptoms, lymphedema in breast cancer survivors

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Vanderbilt University School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

laser alone

mld alone

laser and mld combined

Arm Description

The intervention was therapist administered low level laser therapy using low level laser, number of sessions based upon patient response

The intervention was therapist administered manual lymphatic drainage (mld) using standard massage techniques,number of sessions based upon patient response

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

Outcomes

Primary Outcome Measures

LDex Change-

Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.

Whole Arm Volume Difference

Whole arm measurement to determine volume.

Secondary Outcome Measures

Symptoms

Yes/no response to a symptom listed on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A) self-report form.

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.

Full Information

NCT ID

NCT00852930

First Posted

February 26, 2009

Last Updated

April 7, 2017

Sponsor

Vanderbilt University

1. Study Identification

Unique Protocol Identification Number

NCT00852930

Brief Title

Low Level Laser Treatment and Breast Cancer Related Lymphedema

Official Title

Low Level Laser Treatment and Breast Cancer Related Lymphedema

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphedema

Keywords

lymphedema, quality of life, breast cancer, symptoms, lymphedema in breast cancer survivors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

laser alone

Arm Type

Experimental

Arm Description

The intervention was therapist administered low level laser therapy using low level laser, number of sessions based upon patient response

Arm Title

mld alone

Arm Type

Active Comparator

Arm Description

The intervention was therapist administered manual lymphatic drainage (mld) using standard massage techniques,number of sessions based upon patient response

Arm Title

laser and mld combined

Arm Type

Experimental

Arm Description

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 Type

Procedure

Intervention Name(s)

laser and MLD combined

Intervention Description

The intervention is therapist administered laser and mld treatment combined

Intervention Type

Procedure

Intervention Name(s)

laser alone

Intervention Description

The intervention is therapist administered laser

Intervention Type

Procedure

Intervention Name(s)

manual lymphatic drainage

Intervention Description

The intervention is therapist administered manual lymphatic drainage

Primary Outcome Measure Information:

Title

LDex Change-

Description

Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.

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.

Title

Whole Arm Volume Difference

Description

Whole arm measurement to determine volume.

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.

Secondary Outcome Measure Information:

Title

Symptoms

Description

Yes/no response to a symptom listed on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A) self-report form.

Time Frame

Self report on last day of treatment with average treatments being 9 conducted over a median of up to 4 weeks.

Title

Quality of Life

Description

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.

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.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

sheila h ridner, phd

Organizational Affiliation

Vanderbilt Univeristy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University School of Nursing

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37240

Country

United States

12. IPD Sharing Statement

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Low Level Laser Treatment and Breast Cancer Related Lymphedema

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