Fife, D., Rayhan, D.J., Behnam, S., Ortiz, A., Elkeeb, L., Aquino, L., . . . Kelly, K.M. (2010). A randomized, controlled, double-blind study of light emitting diode photomodulation for the prevention of radiation dermatitis in patients with breast cancer. Dermatologic Surgery: Official Publication for American Society for Dermatologic Surgery [Et Al.], 36(12), 1921–1927.

To further evaluate the efficacy of light emitting diode (LED) photomodulation in lessening radiation dermatitis   

Patients in both arms of the study received a complete course of radiation therapy (RT) for breast cancer. Patients were assigned randomly to the treatment or control group. In the treatment arm, patients received LED treatment immediately before and after each RT treatment. The LED treatment consisted of using the GentleWaves Select 590 nm high-energy LED array, with the panel being placed 2 cm from the patients skin. The treatment lasted 35 seconds. At the completion of RT, patients received seven additional daily treatments over the following two weeks. The control group received sham treatments in which the GentleWaves Select machine was placed on the skin in the same manner as the treatment arm and for the same duration of 35 seconds, but the on button was not pressed to deliver the LED treatment. All patients also used Aquaphor applied three to four times a day during the duration of the study.

• The study sample (N = 33) was comprised of patients diagnosed with breast cancer undergoing radiation therapy.
• Patients were aged 18 years or older.
• All patients had undergone lumpectomy or mastectomy.
   

The study took place in the Department of Radiation Oncology at the University of California Irvine Medical Center.

Patients were undergoing the transition phase of care after initial treatment. The study has clinical applicability for late effects and survivorship.

The study used a single-center, double-blind, randomized, placebo-controlled design.

• The National Cancer Institute five-point scale for grading skin reactions was used.

In the LED treatment arm (N = 18), no patients had a grade 0 reaction, 6 (33%) had grade 1 reactions, and 12 (66.7%) had grade 2 reactions; no grade 3 or 4 reactions developed. In the sham treatment arm (N = 15), 1 (6.6%) had a grade 0 reaction, 4 (26.7%) had grade 1 reactions, 9 (60%) had grade 2 reactions, and 1 (6.7%) had a grade 3 reaction. Two patients (11.1%) in the LED arm and one (6.7%) in the sham arm had to interruption to treatment.

LED photomodulation did not provide statistically significant differences between the two groups.

• The study had a small sample size, with less than 30 participants.
• A blinded dermatologist performed evaluations of skin reactions based on photographs as opposed to real-time evaluations performed by a nurse at the time of treatment.   
   

No firm conclusions regarding efficacy of LED light for prevention of radiodermatitis can be drawn from this study.