LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis

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.