Low-Level Laser in Head and Neck Chronic Lymphedema

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of low-level laser treatment (LLLT) on the severity of lymphedema, symptom burden, functional status, and quality of life in HNC survivors.

Detailed Description
-----------------
Primary aim: To determine the impact of LLLT, as compared to wait-list control, on changes in severity of lymphedema. Secondary aim: To determine the impact of LLLT, as compared to a wait-list control, on lymphedema-related symptom burden (e.g., tightness), functional impairments (e.g., range of motion in jaw and neck), and quality of life.

Official Title
-----------------
Low-level Laser in Treatment of Head and Neck Chronic Lymphedema: A Pilot Randomized Controlled Trial

Conditions
-----------------
Head and Neck Cancer, Lymphedema, Fibrosis

Intervention / Treatment
-----------------
* Device: Low-level laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years of age >6 months post HNC treatment No evidence of cancer confirmed with imaging tests Having head and neck lymphedema with or without fibrosis Completion of initial lymphedema therapy Lymphedema duration between 3-24 months Ability to speak and read English Ability 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 Acute infection Photosensitivity Chronic inflammatory diseases Venous thrombosis Carotid artery stenosis History of severe trauma Medication that affects body fluid and electrolyte balance Use of high doses of non-steroidal anti-inflammatory drugs Pre-existing skin rash, ulceration, open wound in the treatment area Active lymphedema therapy or physical therapy Allergic and other systemic skin diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, wait-list control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (laser group)<br>Group 1 (laser group): After completion of the baseline measurements, Group 1 participants will be scheduled for LLLT. After completion of LLLT, participants will be scheduled for the 4-week and 8-week follow up data collection. | Device: Low-level laser<br>* Low-level laser therapy<br>|
| No Intervention: Group 2 (wait-list control group)<br>Group 2 (wait-list control group): Group 2 participants will not undergo LLLT therapy but will complete all the same study assessments as the laser therapy group, including the baseline, and follow-up assessments. After the 8-week follow-up assessment, participants will be offered the same LLLT as the laser group. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients with reduced severity of lymphedema and fibrosis | Head and Neck Lymphedema and Fibrosis Assessment Criteria | Up to 8-week post-LLLT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom burden score | Head and Neck Lymphedema and Fibrosis Symptom Inventory | Up to 8-week post-LLLT | 
| Neck range of motion degree | Cervical Range of Motion Device | Up to 8-week post-LLLT | 
| Quality of life score | EORTC QLQ-H&N35 | Up to 8-week post-LLLT |