Low Level Laser Treatment and Breast Cancer Related Lymphedema
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2009 |
| End Date: | April 2012 |
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.
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.
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.
(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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
