Low Level Laser Treatment and Breast Cancer Related Lymphedema

NCT ID: NCT00852930

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-04-30

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.

Conditions

Lymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

laser alone

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

Group Type: EXPERIMENTAL

laser alone

Intervention Type: PROCEDURE

The intervention is therapist administered laser

mld alone

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

Group Type: ACTIVE_COMPARATOR

manual lymphatic drainage

Intervention Type: PROCEDURE

The intervention is therapist administered manual lymphatic drainage

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

Group Type: EXPERIMENTAL

laser and MLD combined

Intervention Type: PROCEDURE

The intervention is therapist administered laser and mld treatment combined

Interventions

laser and MLD combined

The intervention is therapist administered laser and mld treatment combined

Intervention Type: PROCEDURE

laser alone

The intervention is therapist administered laser

Intervention Type: PROCEDURE

manual lymphatic drainage

The intervention is therapist administered manual lymphatic drainage

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Sheila Ridner

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sheila h ridner, phd

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt Univeristy

Locations

Vanderbilt University School of Nursing

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

090118

Identifier Type: -

Identifier Source: org_study_id