LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis

Study Overview
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Brief Summary
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Radiation dermatitis is a common side-effect of radiation therapy in cancer patients who frequently can experience redness, pain, crusting, and even ulceration of the skin causing suffering and treatment interruption. A recent retrospective study by DeLand demonstrated that administering light emitting diode (LED) photomodulation after each radiation treatment for breast cancer decreased radiation dermatitis in a majority of patients. LED photomodulation is a process by which specific sequences of light are used to regulate or manipulate cell activity without causing heat or damage to the skin. Each LED treatment is painless and is completed in usually less than one minute. LED photomodulation may reduce the suffering associated with radiation treatments, improve cosmetic outcome in radiation fields, and eliminate breaks in radiation treatments which may be required because of severe ulcerating reactions. This study will attempt to replicate the findings of Dr. DeLand's study by randomly assigning at least 40 breast cancer patients to either a treatment group or to a control group. The treatment group will receive LED photomodulation treatments before and after each radiation treatment with the Gentlewaves Select™ handheld high energy 590nm LED array using specific sequences of pulses used in other studies; the treatment group will also receive 7 additional treatments over 2 weeks after their radiation treatment course is completed. The control group will receive no LED treatment but will use the exact same skin care regimen as the treatment group. In addition to weekly evaluation and grading of skin reactions, subjects will be photographed under standardized conditions weekly and then photographs will be evaluated and graded by blinded dermatologists.

Official Title
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LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis: A Prospective, Randomized, Controlled Study

Conditions
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Radiation Dermatitis

Intervention / Treatment
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* Device: Gentlewaves Select™ handheld high energy LED array
* Radiation: Radiation
* Radiation: Radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have clinically diagnosed breast or head and neck cancer that will be treated with radiation therapy. Subjects must be at least 18 years of age Exclusion Criteria: Subjects will not be eligible to participate if they are pregnant or lactating. Patients treated with partial breast irradiation techniques, brachytherapy, or other non-standard techniques will not be eligible.

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: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The enrollment goal of 40 includes 20 for each arm.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>LED treatment with Gentlewaves Select™ handheld high energy LED array 5 to 10 minutes before each radiation treatment and again 5-10 minutes after each radiation treatment | Device: Gentlewaves Select™ handheld high energy LED array<br>* LED photomodulation within 5-10 minutes before and within 5-10 minutes after each radiation treatment<br>Radiation: Radiation<br>* Weekly radiation treatment<br>|
| Other: Control<br>Radiation only | Radiation: Radiation<br>* Weekly radiation treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine efficacy |  | 6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dermatitis, skin, radiation, light, LED photomodulation, Gentlewaves