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

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ClinicalTrials.gov Identifier: NCT03738332
Recruitment Status : Recruiting
First Posted : November 12, 2018
Last Update Posted : August 13, 2019
Sponsor:
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)
Estimated Enrollment : 25 participants
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 : July 31, 2020
Estimated Study Completion Date : July 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

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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.


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


Contacts
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Contact: Jie Deng, PhD

Locations
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United States, Pennsylvania
University of Pennsylvania Abramson Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jie Deng, PhD    215-573-2393    jiedeng@nursing.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania

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Responsible Party: Jie Deng, Associate Professor, PhD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03738332     History of Changes
Other Study ID Numbers: UPCC12318
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Lymphatic Diseases