Hoopfer, D., Holloway, C., Gabos, Z., Alidrisi, M., Chafe, S., Krause, B., . . . Severin, D. (2015). Three-arm randomized phase III trial: Quality aloe and placebo cream versus powder as skin treatment during breast cancer radiation therapy. Clinical Breast Cancer, 15, 181–190.

To test the hypothesis that the use of aloe would lead to a one-point reduction in radiation-induced skin rash (RISR) severity and a decrease in symptom severity compared to a traditional dry powder skin care regimen

Potentially eligible patients underwent a skin test to rule out allergic reactions. Informed consent was obtained, and patients were randomized to each arm (aloe, placebo cream, or control powder). The creams were dispensed in identically labeled containers to the patients with study protocol directions. Two radiation oncology nurses trained to identify RISR assessed acute skin reactions and completed scoring at weeks 1, 2, and 4. All patients were asked to either use no soap or mild soap and to apply baby powder or cornstarch to the treatment skin markings. Patients in the powder arm applied powder during treatment followed by one month of a moisturizing cream. Those in the cream arm applied it three times per day throughout treatment and for one month after completion. Additional treatment for moist desquamation and other skin reactions was administered according to individual physician preferences.

• N = 237
• AGE = > 18 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Nonmetastatic breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Previous mastectomy or segmented resection; agreement to comply with the study protocol; received either 45 Gy in 20 fractions or 50 Gy in 25 fractions; approximately 40% were current smokers

• SITE: Single-site
• SETTING TYPE: Outpatient
• LOCATION: Canada

• PHASE OF CARE: Active antitumor treatment

Single-blinded, placebo-controlled, randomized trial

• Modified 10-point Catterall skin scoring profile

Patients were studied during a 21-month period. Ten withdrew before the start of the study, and one withdrew because of a selection error. Skin rashes occurred in all three arms with the greatest number of skin rashes noted in the aloe cream arm (31% compared to 15.6% with a placebo). Skin reaction scores were consistently higher with aloe than with the standard treatment of powder (p < 0.02). The study also showed that patients in the powder arm reported more dryness, pain, and itching (p = 0.0163). This study did not meet the endpoint of a change in the RISR severity of one point. Women with breast cup sizes C and greater experienced a significantly higher severity of skin reactions (p < 0.02). It also was noted that erythema and dry desquamation occurred more with powder, and moist desquamation (< 50%) occurred most with aloe cream and (> 50%) occurred most with powder.

The results of the study showed that known-quality aloe or placebo creams did not improve skin reactions or symptoms; they made them worse. The study also concluded that dry skin was better than moist treatment during radiation treatment.

• Baseline sample/group differences of import
• Measurement/methods not well described
• Other limitations/explanation: The treatment of moist desquamation was not standardized, so physicians could order whatever was deemed medically necessary. The study did not disclose whether any of the study patients fell into that category. A significantly higher proportion of patients in the aloe and placebo arms received chemotherapy as well. It appears that radiation therapy did not employ intensity-modulated radiation therapy. The use of powder on the skin is not common as a standard of practice.

Patient education is very important, and patients should be instructed to use only skin care products that will be effective in managing radiodermatitis. This study had some limitations, but it adds to the growing body of evidence that aloe can make radiation skin reactions worse. Patients should be instructed to not use aloe products on their skin.