LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis
Primary Purpose
Radiation Dermatitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gentlewaves Select™ handheld high energy LED array
Radiation
Radiation
Sponsored by
About this trial
This is an interventional device feasibility trial for Radiation Dermatitis focused on measuring dermatitis, skin, radiation, light, LED photomodulation, Gentlewaves
Eligibility Criteria
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.
Sites / Locations
- Chao Family Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Treatment
Control
Arm Description
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
Radiation only
Outcomes
Primary Outcome Measures
Determine efficacy
Secondary Outcome Measures
Full Information
NCT ID
NCT00573365
First Posted
December 12, 2007
Last Updated
August 1, 2017
Sponsor
University of California, Irvine
1. Study Identification
Unique Protocol Identification Number
NCT00573365
Brief Title
LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis
Official Title
LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis: A Prospective, Randomized, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Dermatitis
Keywords
dermatitis, skin, radiation, light, LED photomodulation, Gentlewaves
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The enrollment goal of 40 includes 20 for each arm.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Other
Arm Description
Radiation only
Intervention Type
Device
Intervention Name(s)
Gentlewaves Select™ handheld high energy LED array
Intervention Description
LED photomodulation within 5-10 minutes before and within 5-10 minutes after each radiation treatment
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
Weekly radiation treatment
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
Weekly radiation treatment
Primary Outcome Measure Information:
Title
Determine efficacy
Time Frame
6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Fife, MD
Organizational Affiliation
Chao Family Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
12. IPD Sharing Statement
Learn more about this trial
LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis
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