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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

Tracking Information
First Submitted Date  ICMJE November 8, 2018
First Posted Date  ICMJE November 12, 2018
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE February 25, 2019
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2018)
  • Recruitment rate [ Time Frame: Up to 12 months ]
    Recruitment rate and barriers to recruitment
  • Completion rate [ Time Frame: Up to 12 months ]
    Barriers to completion of the study intervention
  • Safety - adverse events rate [ Time Frame: Up to 12 months ]
    Adverse events
  • Patient satisfaction rate [ Time Frame: Up to 12 months ]
    Patient satisfaction rate
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03738332 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study
Official Title  ICMJE Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Pre-and post design
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Head and Neck Cancer
  • Lymphedema
  • Fibrosis
Intervention  ICMJE Device: Low-Level Laser
Low-level laser therapy
Study Arms  ICMJE Low-level laser therapy
Single arm
Intervention: Device: Low-Level Laser
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 8, 2018)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jie Deng, PhD
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03738332
Other Study ID Numbers  ICMJE UPCC12318
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jie Deng, University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Pennsylvania
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP