Heggie, S., Bryant, G. P., Tripcony, L., Keller, J., Rose, P., Glendenning, M., & Heath, J. (2002). A phase III study on the efficacy of topical aloe vera gel on irradiated breast tissue. Cancer Nursing, 25, 442–451.

To see if topical aloe vera gel would be beneficial in reducing the skin side effects of radiation therapy (RT).

Participants were stratified according to bra cup size, history of lymphocele drainage, and smoking. Participants were randomized to use of aloe vera or an aqueous cream for control.

• The sample was comprised of 208 participants with breast cancer.
• Median age was 57.5 years (range 28–89).
• Patients had undergone lumpectomy or partial mastectomy.
• Median radiation dose was 60.15 Gy.

Mater Centre, Australia, and the Royal Brisbane Hospital Centre, Australia

The study was a randomized, controlled, double-blind trial.

• Weekly assessment form based on Dische’s Morbidity Rating Scale was used to record skin reactions.
• Researchers observed for erythema, itching, pain, and extent of treatment area affected by dry or moist desquamation. The areas affected by moist desquamation were identified according to site.
• Weight, skin type, tumor stage, and previous skin cancer were also recorded.
• Weekly assessments were performed using the Radiation Therapy Oncology Group (RTOG) scale.
• Skin changes recorded were itching, skin texture, tanning, erythema, time to skin change, and dose at first skin change.

Aqueous cream was significantly better than aloe vera gel in reducing the incidence of dry desquamation and moderate or higher pain (p < 0.001). Participants with cup size D or more in either treatment arm experienced a significantly greater incidence of moderate or higher erythema compared with smaller-breasted women (p < 0.02). For non-chemotherapy participants, the aloe vera arm experienced a significantly reduced incidence of moderate or higher erythema (p = 0.02). The control group arm experienced a significantly reduced incidence of moderate or higher pain (p = 0.03). The most important predictors of development of skin reaction were radiation dose, breast size, patient smoking, and damage to the lymphatic system manifested by one or more lymphocele drainage. Cumulative dose was greater than 2,700 cGy, and there was a delay to onset of erythema (p = 0.013).

Aqueous cream is superior to aloe vera in reducing the acute RT skin reactions of dry desquamation and pain.

• The consistency and appearance of the two study preparations were quite dissimilar, so participants may have guessed the identity of their study preparation.
• Ninety percent of the final skin assessments were conducted over the telephone, so the research nurse was not able to view the participant’s skin and had to rely on the subjective assessment.