Clinical trial NCT00852930: Low Level Laser Treatment and Breast Cancer Related Lymphedema
Official title: Low Level Laser Treatment and Breast Cancer Related Lymphedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lymphedema
Keywords: lymphedema
quality of life
breast cancer
symptoms
lymphedema in breast cancer survivors
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2009-02-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: LDex Change-
timeFrame: Bioimpedance at baseline and end of treatment with the average number of treaments being 9 conducted over a median of up to 4 weeks.
measure: Whole Arm Volume Difference
timeFrame: Baseline and on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.
Secondary outcomes:
measure: Symptoms
timeFrame: Self report on last day of treatment with average treatments being 9 conducted over a median of up to 4 weeks.
measure: Quality of Life
timeFrame: Self-report on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University School of Nursing
state: Tennessee
Study officials:
affiliation: Vanderbilt Univeristy
name: sheila h ridner, phd
role: PRINCIPAL_INVESTIGATOR
References: