Enomoto, T.M., Johnson, T., Peterson, N., Homer, L., Walts, D., & Johnson, N. (2005). Combination glutathione and anthocyanins as an alternative for skin care during externalbeam radiation. American Journal of Surgery, 189, 627–631.

DOI Link

Study Purpose

To evaluate if the topical application RayGel (contains glutathione and anthocyanin) decreases radiation dermatitis

Intervention Characteristics/Basic Study Process

Both groups received instruction in standard skin care and used aloe vera gel and vitamin E after treatment. Gel or placebo was applied to breasts one to three hours prior to radiation therapy. The placebo was a water-based gel.

Sample Characteristics

  • The study sample was comprised of 30 female patients with breast cancer.
  • Mean age was 54.9 years (SD = 8.3 years) in the placebo group and 62.5 years (SD =12.2 years) in the RayGel group.
  • Average treatment was 180–200 cGy per day.

Study Design

The study used a prospective, placebo-controlled design.

Measurement Instruments/Methods

  • Skin reactions were evaluated using modified Radiation Therapy Oncology Group skin toxicity scoring.
  • The breast was divided in to nine regions and then each region was assigned a grade (0–4). The score was calculated for each of the nine breast regions by multiplying the grade of skin reaction by the percentage of area within that region. The whole breast score was the sum of the nine regions. A separate score was calculated for the area with the worst degree of skin reaction.

Results

Whole breast severity scores were lower with RayGel at 93.7% versus the placebo at 123%. The difference in the worst site score was not as pronounced; however, the RayGel Group was 14% less than that of the placebo group, at 39.2% and 45.5%, respectively. None of the findings were significant.

Conclusions

RayGel tended to be superior to the placebo, although significance could not be determined because of the small sample size.

Limitations

  • The sample size was small, with less than 50 participants.
  • All patients were using aloe and Vitamin E; use of multiple topical treatments confounds results.
  • Modified Radiation Therapy Oncology Group scoring is difficult to compare with other studies not using modified scoring.