The purpose of this Phase 2 Breast Skin Care Pilot Study was to compare the acute skin reaction in patients undergoing radiation therapy for early breast cancer who use Aloe vera gel on the irradiated skin, with the acute skin reaction in patients from our earlier study who followed a normal skin care routine. Two secondary objectives were to assess patient compliance with the use of Aloe vera gel and the ease of using two skin toxicity scoring tools.

A total of 109 patients undergoing radiotherapy following surgery for breast cancer between October 1997 and February 1998 consented to participate in this study. Each patient applied the Aloe vera gel three times daily to the irradiated area during radiation treatment. Skin reactions were assessed objectively on a weekly basis during radiation using the Radiation Therapy Oncology Group (RTOG) and the Acute Skin Reaction Index (ASRI) skin scoring tools and subjectively by patients. All patients were followed for up to 3 weeks following treatment.

The use of Aloe vera gel did not increase the acute skin reactions due to irradiation when compared with the two arms of the previous Phase 1 Breast Skin Care Study. This pilot study demonstrated that patients could safely use Aloe vera gel while undergoing radiation therapy treatments. All patients complied uniformly with the instructions of using the gel during the study. The ASRI skin scoring tool was easier to use and more sensitive in displaying differences in skin reactions in comparison to the RTOG scale.