NCT00573365

LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radiation Dermatitis

Interventions

Type	Name	Description
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
RADIATION	Radiation	Weekly radiation treatment

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-07-01
• Completion: 2008-08-01
• First posted: 2007-12-14
• Last updated: 2017-08-02

Locations

1 site across 1 country: United States