Skip to main content
OpenTrials
Completed

NCT Number: NCT00852930

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lymphedema Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Vanderbilt University School of Nursing

Nashville, Tennessee, 37240, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laser and MLD combined

Procedure

The intervention is therapist administered laser and mld treatment combined

laser alone

Procedure

The intervention is therapist administered laser

Manual Lymphatic Drainage

Procedure

The intervention is therapist administered manual lymphatic drainage

Primary outcomes

  1. LDex Change-

    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.

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

  2. Whole Arm Volume Difference

    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.

    Whole arm measurement to determine volume.

Secondary outcomes

  1. Symptoms

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

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

  2. 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.

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Feb 27, 2009
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.