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Sponsored by: |
University of California, Irvine |
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Information provided by: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00573365 |
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.
Condition | Intervention |
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Radiation Dermatitis |
Device: Gentlewaves Select™ handheld high energy LED array Radiation: Radiation |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis: A Prospective, Randomized, Controlled Study |
Estimated Enrollment: | 40 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Treatment: Experimental
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
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Device: Gentlewaves Select™ handheld high energy LED array
LED photomodulation within 5-10 minutes before and within 5-10 minutes after each radiation treatment
Radiation: Radiation
Weekly radiation treatment
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Control
Radiation only
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Radiation: Radiation
Weekly radiation treatment
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Chao Family Comprehensive Cancer Center | |
Orange, California, United States, 92868 |
Principal Investigator: | Douglas Fife, MD | Chao Family Comprehensive Cancer Center |
Responsible Party: | Chao Family Comprehensive Cancer Center ( Douglas Fife, MD ) |
Study ID Numbers: | UCI 06-46 |
Study First Received: | December 12, 2007 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00573365 |
Health Authority: | United States: Institutional Review Board |
dermatitis skin radiation |
light LED photomodulation Gentlewaves |
Skin Diseases Wounds and Injuries Disorders of Environmental Origin |
Radiodermatitis Radiation Injuries Dermatitis |