Wencesley Paez MD, Presenter: Nothing to Disclose

Thomas Johnson MD, Abstract Co-Author: Nothing to Disclose

Nathalie Johnson MD, Abstract Co-Author: Nothing to Disclose

Noel Peterson ND, Abstract Co-Author: Nothing to Disclose

Deb Walts RN, Abstract Co-Author: Nothing to Disclose

Measures to decrease the incidence of significant radiodermatitis continues to be sought. Progressive radiodermatitis during whole breast irradiation can result in treatment delays which may impact effectiveness in therapy. RaygelTM does have anti-oxidant properties and may be radioprotective. We performed a small pilot study using RaygelTM (a combination of reduced glutathione and anthocyanins) which showed efficacy. During the pilot we discovered that the formulation of RayGelTM had a short shelf-life and needed better stabilization. We embarked on this study to compare a reformulated RaygelTM cream to placebo cream to determine its ability to reduce radiodermatitis and lower morbidity during external beam radiation therapy of the breast.

Post-lumpectomy breast cancer patients undergoing whole breast irradiation were prospectively randomized to treatment with placebo or RaygelTM. Patients, physicians and staff were blinded. Skin reactions were documented by photographs and scored using the standard skin reaction severity scale. Patients were instructed to apply either topical RaygelTM or placebo cream 30-90 minutes prior to their radiation treatment for a 5-week period. Both groups applied standard skin care of vitamin E oil and Aloe vera. Breast volumes were calculated using CT dosimetry. Comfort surveys were obtained at the end of treatment. Total breast scores and worst site breast scores were computed and compared. Statistical analysis was performed using student’s t-test.

131 patients were consented and enrolled. 14 patients withdrew for a total of 117 evaluable. 60 patients were assigned to the placebo group and 57 to the RayGelTM group. Total Breast Scores were calculated by percent of skin involved and grade of skin reaction. The placebo group had a higher mean Total Breast Severity Score of 126% versus RayGelTM of 111% (p = 0.09). Worst site severity scores were 49% for the placebo group versus 41% for the RaygelTM group. The placebo group had a higher mean Discomfort Score of 2.47 versus 2.22 for the RayGelTM group.

RaygelTM provides superior skin protection during radiation therapy than that observed with standard skin care and placebo. Patients using RaygelTM trended toward less discomfort at the end of treatment versus patients receiving placebo. Daily application of RaygelTM during the course of whole breast irradiation reduces the severity of dermatitis and may facilitate completion of therapy without treatment breaks.

Paez, W, Johnson, T, Johnson, N, Peterson, N, Walts, D, Combined Glutathione and Anthocyanins: An Improved Alternative for Skin Care during External Beam Radiation.  Radiological Society of North America 2008 Scientific Assembly and Annual Meeting, February 18 - February 20, 2008 ,Chicago IL. http://archive.rsna.org/2008/7000186.html