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

January 25, 2022 updated by: Jie Deng, University of Pennsylvania
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Abramson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Low-level laser therapy
Single arm
Device: Low-Level Laser
Low-level laser therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Consented and Enrolled in Study
Time Frame: Approximately 5-month recruitment window
Number of participants who consented the study and number of participants who enrolled in the study
Approximately 5-month recruitment window
Number of Participants Completed the Study Visits
Time Frame: Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
Number of participants who completed the study visits
Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
Number of Participants With Adverse Events
Time Frame: Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
Number of participants who experienced adverse events during the course of the study.
Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
Number of Participants Who Were Satisfied With Study Intervention.
Time Frame: at 4-week post-intervention visit
Participants were interviewed by the study staff to ask whether they were satisfied or unsatisfied with the study intervention (low-level laser therapy).
at 4-week post-intervention visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

November 8, 2018

First Submitted That Met QC Criteria

November 8, 2018

First Posted (Actual)

November 13, 2018

Study Record Updates

Last Update Posted (Actual)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC12318

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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