Low Level Laser Treatment and Breast Cancer Related Lymphedema

• ClinicalTrials.gov Identifier: NCT00852930
• Recruitment Status: Completed
• First Posted: February 27, 2009
• Results First Posted: November 1, 2015
• Last Update Posted: April 11, 2017
• Sponsor: Vanderbilt University
• Information provided by (Responsible Party): Sheila Ridner, Vanderbilt University

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.

Condition or disease	Intervention/treatment	Phase
Lymphedema	Procedure: laser and MLD combined; Procedure: laser alone; Procedure: manual lymphatic drainage	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Low Level Laser Treatment and Breast Cancer Related Lymphedema
• Study Start Date: September 2009
• Actual Primary Completion Date: April 2012
• Actual Study Completion Date: April 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: laser alone; The intervention was therapist administered low level laser therapy using low level laser, number of sessions based upon patient response	Procedure: laser alone; The intervention is therapist administered laser
Active Comparator: mld alone; The intervention was therapist administered manual lymphatic drainage (mld) using standard massage techniques,number of sessions based upon patient response	Procedure: manual lymphatic drainage; The intervention is therapist administered manual lymphatic drainage
Experimental: 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	Procedure: laser and MLD combined; The intervention is therapist administered laser and mld treatment combined

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Tennessee

Vanderbilt University School of Nursing

Nashville, Tennessee, United States, 37240

Sponsors and Collaborators

Vanderbilt University

Investigators

• Principal Investigator: sheila h ridner, phd; Vanderbilt Univeristy

More Information

• Responsible Party: Sheila Ridner, professor, Vanderbilt University
• ClinicalTrials.gov Identifier: NCT00852930
• Other Study ID Numbers: 090118
• First Posted: February 27, 2009
• Results First Posted: November 1, 2015
• Last Update Posted: April 11, 2017
• Last Verified: April 2017

Keywords provided by Sheila Ridner, Vanderbilt University:

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

Additional relevant MeSH terms:

Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Lymphatic Diseases; Postoperative Complications; Pathologic Processes