Raygel Clinical Trials

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RayGel Clinical Trial Results:

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.

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.

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Fig. A Breast treated with Raygel

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Fig. B Breast 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.

 

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RAYGEL TRIAL OUTCOME CARRIED OUT INDEPENDENTLY BY LEGACY CANCER SERVICES

Legacy Cancer Services provides a multidisciplinary, comprehensive range of services designed to help patients and their families through the diagnosis, treatment and recovery of their cancer.

Extract:
Conclusion: Raygel provides superior skin protection during radiation therapy than that observed with standard skin care and placebo. RayGel averaged better comfort scores than placebo. Application of combined glutathione/ anthocyanins results in lower severity radiodermatitis at completion of whole breast therapy.

Application advice

  • Before application, wash hands thoroughly with soap and water.
  • Apply the purple-coloured RayGel with your fingertips for approximately 2-3 minutes into the skin area, and massage until the gel is no longer visible.
  • RayGel should be applied 60 minutes prior to any radiation.
  • The application of the gel should be repeated after 2 hours of any radiation exposure, such as the sun, solarium or radiotherapy.
  • Avoid contact with eyes. Do not take internally. Keep out of reach of children. Store tightly closed in a cool, dry place. As with any product, discontinue use if adverse effects occur.
  • RayGel has not been tested on animals. 

Directions of use:

Wash hands thoroughly with soap and water.
On the appropriate application zone, the purple-coloured gel should be applied with the fingertips and massaged  into the skin for 2-3 minutes, until the gel is no longer visible.
Usually, the gel is applied from the collarbone down over the entire chest to the underarm area (see picture).
RayGel should be applied approximately 60-90 minutes before irradiation treatment.
After 3 minutes of massaging in to the skin, remove any excess gel which has not absorbed.
The gel should also be applied to the area 4-8 hours after irradiation
On radiation-free days, the gel should be applied 2x daily (1x morning and 1 evening).
The gel should be stored at room temperature.

(Please note that the entire area to be irradiated, including the nipples were previously treated with the gel).

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