NCT01351376

Brief Summary

This study aims to explore the effects of Low Level Laser Therapy (LLLT) on breast cancer-related lymphedema when utilized in conjunction with Complex Decongestive Therapy (CDT) when compared to CDT treatment alone. The investigators hypothesize that the addition of LLLT to CDT will result in statistically significant improvements and greater long-term benefits as measured by changes in arm volume and quality of life when compared to the benefits of CDT alone for the treatment of breast cancer-related lymphedema.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

September 19, 2019

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

5.1 years

First QC Date

May 9, 2011

Results QC Date

December 5, 2017

Last Update Submit

September 18, 2019

Conditions

Breast CancerLymphedema

Keywords

Lymphedema, Low Level Laser, Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Arm Volume

    13 Months

Secondary Outcomes (1)

  • Short-Form Health Survey (SF-36)

    13 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

CDT + inactive LLL

Device: Low Level Laser Therapy

LLL combined with CDT

ACTIVE COMPARATOR

CDT + active LLL

Device: Low Level Laser

Interventions

Low Level Laser TherapyDEVICE

Placebo LLL combined with CDT

Also known as: Low Level Laser, Complex Decongestive Therapy
Placebo
Low Level LaserDEVICE

Active LLL combined with CDT

Also known as: Complex Decongestive Therapy
LLL combined with CDT

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral breast cancer with ipsilateral lumpectomy or mastectomy and lymph node dissection (sentinel biopsy or axillary dissection)
  • stage II or III unilateral secondary upper extremity lymphedema (as defined by the International Society of Lymphology)
  • girth ≥ 2 cm circumferential difference and/or volume ≥ 200 mL compared to the uninvolved upper extremity at any 4 cm segment
  • able to commit to a long term follow-up schedule

You may not qualify if:

  • active cancer/metastatic cancer
  • currently receiving or have plans for adjuvant radiation or chemotherapy
  • pregnant
  • presence of other extremity lymphedema (primary or secondary)
  • pacemaker
  • artificial joints in the upper quadrants
  • renal failure
  • arterial insufficiency
  • congestive heart failure
  • chronic inflammatory conditions
  • history of deep vein thrombosis (DVT) in the lymphedematous upper extremity
  • previous treatment with Low Level Laser (regardless of indication)
  • medication(s) known to affect body fluid balance
  • body mass index (BMI) \> 40 (morbid obesity)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

NYU Clinical Cancer Center

New York, New York, 10016, United States

Location

NYU Rusk Institute of Rehabilitation Medicine

New York, New York, 10016, United States

Location

Tisch Hospital

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsLymphedema

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Results Point of Contact

Title
Tara Denham, MD
Organization
Rehabilitation Medicine, New York University School of Medicine
Tara.Denham@nyumc.org
212 263 8240

Study Officials

  • Teresa Denham, PT, MA

    NYU Rusk Institute of Rehabilitation Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2011

First Posted

May 10, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2016

Study Completion

July 1, 2017

Last Updated

September 19, 2019

Results First Posted

September 19, 2019

Record last verified: 2019-09

Locations

US(3)