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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. Identifier: NCT03738332
Recruitment Status : Completed
First Posted : November 13, 2018
Last Update Posted : February 9, 2021
Information provided by (Responsible Party):
Jie Deng, University of Pennsylvania

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 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
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

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

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

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.

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

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.

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 identifier (NCT number): NCT03738332

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United States, Pennsylvania
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
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Responsible Party: Jie Deng, Associate Professor, PhD, University of Pennsylvania Identifier: NCT03738332    
Other Study ID Numbers: UPCC12318
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Lymphatic Diseases