Low Level Laser Treatment and Breast Cancer Related Lymphedema

NCT00852930 | Completed Phase 4 Results

• 1 other identifier: 090118
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema

Keywords

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

Outcome Measures

Primary Outcomes (2)

• LDex Change-

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

  Bioimpedance at baseline and end of treatment with the average number of treaments being 9 conducted over a median of up to 4 weeks.

• Whole Arm Volume Difference

  Whole arm measurement to determine volume.

  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 (2)

• Symptoms

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

• Quality of Life

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

Study Arms (3)

laser alone

EXPERIMENTAL

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

Procedure: laser alone

mld alone

ACTIVE COMPARATOR

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

Procedure: manual lymphatic drainage

laser and mld combined

EXPERIMENTAL

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

Interventions

laser and MLD combined PROCEDURE

The intervention is therapist administered laser and mld treatment combined

laser and mld combined

laser alone PROCEDURE

The intervention is therapist administered laser

laser alone

manual lymphatic drainage PROCEDURE

The intervention is therapist administered manual lymphatic drainage

mld alone

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University School of Nursing

Nashville, Tennessee, 37240, United States

Location

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Interventions

Lasers; Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Sheila H, Ridner, PHD
• Organization: Vanderbilt University School of Nursing

Sheila.Ridner@Vanderbilt.edu

615-322-0831

Study Officials

• sheila h ridner, phd

  Vanderbilt Univeristy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: February 27, 2009
• Study Start: September 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 11, 2017
• Results First Posted: November 2, 2015

Record last verified: 2017-04

Locations

US (1)