Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03738332
Recruitment Status : Active, not recruiting
First Posted : November 13, 2018
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Jie Deng, University of Pennsylvania

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this pilot clinical trial is to evaluate the feasibility of the use of low-level laser for head and neck cancer survivors with lymphedema.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Lymphedema Fibrosis Device: Low-Level Laser Not Applicable

Detailed Description:

Primary aim:

To determine the feasibility of the use of LLLT for HNC survivors with lymphedema, specifically to 1) obtain recruitment estimates and determine barriers to recruitment; 2) identify barriers to implementation; 3) assess safety; and 4) evaluate patient satisfaction.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pre-and post design
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Low-level laser therapy
Single arm
 Device: Low-Level Laser
Low-level laser therapy


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: Up to 12 months ]
    Recruitment rate and barriers to recruitment

  2. Completion rate [ Time Frame: Up to 12 months ]
    Barriers to completion of the study intervention

  3. Safety - adverse events rate [ Time Frame: Up to 12 months ]
    Adverse events

  4. Patient satisfaction rate [ Time Frame: Up to 12 months ]
    Patient satisfaction rate


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >18 years of age
  • Completion of either postoperative radiation or chemoradiation therapy
  • No evidence of cancer
  • Having head and neck external lymphedema
  • Either completion of lymphedema therapy or not in active lymphedema therapy
  • Ability to speak and read English
  • Able to provide informed consent

Exclusion Criteria:

Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of LLLT: pregnancy; photosensitivity; chronic inflammatory diseases; venous thrombosis; history of severe trauma; medication that affects body fluid and electrolyte balance; use of high doses of non-steroidal anti-inflammatory drugs; or pre-existing skin rash, ulceration, open wound in the treatment area; and allergic and other systemic skin diseases.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03738332


Locations
Layout table for location information
United States, Pennsylvania
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jie Deng, Associate Professor, PhD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03738332    
Other Study ID Numbers: UPCC12318
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphedema
Lymphatic Diseases