RayGel Clinical Trial

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Title: Combined Glutathione And Anthocyanins – An Improved Alternative For Skin Care During External Beam Radiation

Introduction: Reduction in radiodermatitis during whole breast irradiation was seen in a pilot trial of Raygel (a combination of reduced glutathione and anthocyanins) but small sample size and short RayGel half-life precluded a statistically significant outcome. Results were however promising and this prompted a larger scale study of Raygel reformulated to an anhydrous base to improve stability and ease of application.

Methods: Patients undergoing whole breast irradiation were prospectively randomized to treatment with placebo or Raygel. Patients, physicians and staff were blinded. Skin reaction was documented by photographs and scored using the standard skin reaction severity scale. Patients were instructed to apply either topical Raygel 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.

raygel breast 1Microsoft Word - RayGel 150 Abstract

 

 

 

 

 

 

Fig. 1. (A) Breast treated with RayGel    

                                                                                                                      Fig. 2. (B) Breast treated with Placebo.  

Results: One hundred thirty-one patients enrolled, 14 patients withdrew for a total of 117 available. 60 assigned to the placebo group and 57 to the RayGel group. Scores were calculated by percent of skin involved and grade of skin reaction. The placebo group had a higher mean Total Breast Score of 126% versus RayGel of 111% (t =0.09). Worst site score was 49% for placebo versus 41% for RayGel. The placebo group had a higher mean discomfort score of 2.47 versus 2.22 for the RayGel group. Figure 1 illustrates two representative photos, both taken at 6 weeks of treatment. Figure 1A shows a patient treated with RayGel. Figure 1B shows a patient treated with placebo.

Conclusion: RayGel provides superior skin protection during radiation therapy than that observed with standard skin care and placebo. Furthermore, RayGel provided less discomfort associated with breast irradiation. Thus, application of RayGel daily during the course of whole breast irradiation may facilitate more consistent completion of therapy without break in treatment of breast cancer.

 

Click here to see clinical trial web page:   http://clinicaltrials.gov/show/NCT00266331

Purpose

This study is for the patient with breast cancer. To take part in this study, external beam radiation therapy needs to be part of the treatment plan. Reduced glutathione, an ingredient of RayGel™, has been helpful in decreasing some radiation therapy side effects to the skin.

Reduced glutathione plays a vital role in both making DNA and cell repair. This study will measure if RayGel decreases skin reaction in breast cancer patients treated with external beam radiation therapy”.