Low Level Laser Therapy for Radiation Induced Dermatitis in H & N Squamous Cell Carcinoma

Study Overview
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Brief Summary
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This study will assess the efficacy of LLLT to mitigate and ameliorate the acneiform-rash, radiation dermatitis, and pain, while assessing its impact on patient reported quality of life.

Detailed Description
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This single-arm phase I/II study establishes the safety and efficacy of low level laser therapy (LLLT) in order to mitigate radiation-induced dermatitis in patients underoing radiation therapy for head and neck squamous cell carcinoma (HNSCC). Additional objectives include assessment of patient-reported quality of life data, pain parameters and dermatologic quality of life responses. The target population is patients with histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx who are candidates for either definitive or adjuvant therapy consisting of a chemotherapy regimen and concurrent radiation therapy. Patients are required to have a favorable performance status (KPS greater than or equal to 70), have had no prior head and neck radiotherapy and be at least 18 years of age and able to provide consent. While receiving radiotherapy and a concurrent systemic regimen, patients will receive LLLT using a 69 diode probe with dual 660 nm and 850 nm wavelengths to at least nine treatment sites in the head and neck region for a duration of 60 seconds to each site. LLLT will be given three times in a week prior to, daily during the first week of, and at least twice weekly thereafter during radiotherapy. Information collected includes toxicity scoring and quality of life surveys. A retrospective matched-pair design will be used to assess the rate of grade III complications compared to patients treated previously without LLLT support, with an anticipated 20% reduction in the risk of grade III dermatitis.

Official Title
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Utilization of Low Level Laser Therapy for Radiation Induced Dermatitis in Patients With Head and Neck Squamous Cell Carcinoma

Conditions
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Radiation Dermatitis

Intervention / Treatment
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* Device: THOR Laser System for Low Level Laser Therapy (LLLT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients ≥ 18 years of age Karnofsky performance status > 70 Histologic proof of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx No prior radiotherapy to the head and neck region. No previous systemic chemotherapy or targeted therapy Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts. Patients using standard therapies for cetuximab-induced acne-form rash will be included. Exclusion Criteria: Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator Concurrent serious infection Continued use of Niacin

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Low Level Laser Therapy<br>Non-invasive, cold laser output treatment. | Device: THOR Laser System for Low Level Laser Therapy (LLLT)<br>* Non-invasive, a cold laser output treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade 3 or higher Adverse Events | Number of patients with documented Grade 3 or higher Adverse Events as per CTCAE v4.0 who receive at least 1 dose of the study treatment. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| University of Washington Quality of Life Questionnaire (UW-QOL) | Patient reported quality of life measured using the University of Washington Quality of Life Questionnaire (UW-QOL), consisting of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains have between 3-6 response options that are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical & mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. | Up to 15 months | 
| Brief Pain Inventory (BPI) | Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. The BPI scale defines pain as follows: Pain Severity: can be measured from Worst pain or the arithmetic mean of the four severity items. 1 - 4 = Mild Pain, 5 - 6 = Moderate Pain, 7 - 10 = Severe Pain. Higher scores indicate greater pain. | Up to 15 months | 
| Dermatology Life Quality Index (DLQI) | Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). | Up to 15 months |