Merchant, T.E., Bosley, C., Smith, J., Baratti, P., Pritchard, D., Davis, T., . . . Xiong, X. (2007). A phase III trial comparing an anionic phospholipid-based cream and aloe vera-based gel in the prevention of radiation dermatitis in pediatric patients. Radiation Oncology, 2, 45.

To compare an APP-based cream and an aloe vera-based gel to determine effectiveness in preventing and treating radiation dermatitis

The side treated with cream or gel was chosen randomly for each patient at the beginning of treatment. The nurse applied aloe vera gel and APP skin cream to the designated study site. Patients were evaluated once during each interval of five treatments and on the last day of treatment by the radiation oncologist. Follow-up examinations were done four to six weeks after completion of radiation therapy, with completion of questionnaires and photographs.

• The study sample was comprised of 45 patients.
• Age ranged from 3–19 years, with a mean of 10 years.
• Of patients in the study, 16 had Hodgkin diseas, 10 a central nervous system tumor, 8 pediatric sarcoma, and 6 neuroblastoma.
• The radiation range was 25.2–67 Gy, with an average total dose of 34.3 Gy.
• Daily fractionation was 1.5–1.8 Gy.

The study took place at St. Jude Children’s Research Hospital in Memphis, TN.

The study used a quasiexperimental design in which patients served as their own controls.

• The primary end point was skin care failure, which included moderate-to-severe dryness, pruritus, erythema, and dry desquamation.
• Skin comfort assessment consisting of 15 items on a four-level scale was completed by the patient or the patient's parent.
• Dermatologic assessment questionnaire of negative items was completed by nursing staff.
• The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (was used.

Some patients rated the APP cream better in terms of comfort and skin dryness. Grouped NCI CTCAE scores were supportive of APP cream (p = 0.004)

APP cream is more effective than aloe vera-based gel for prevention and treatment of radiation dermatitis.

• The applicability to adult patients has not been studied.
• No control group to enable determination of actual effectiveness of either product independently.
• The study had a small sample size, with less than 50 patients.
• Too much variation in time frame for follow-up visits.