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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Head and Neck Cancer, Lymphedema, Fibrosis

Intervention / Treatment
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* Device: Low-Level Laser


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Pre-and post design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Low-level laser therapy<br>Single arm | Device: Low-Level Laser<br>* Low-level laser therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Consented and Enrolled in Study | 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 | 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 | 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. | 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 |