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 anionic polar phospholipid (APP)–based cream and an aloe vera–based gel to determine their effectiveness in preventing and treating radiodermatitis.

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 a radiation oncologist. Follow-up examinations were done four to six weeks after the completion of radiation therapy (RT).

• The sample was comprised of 45 participants. 
• Average age was 10 years (range 3–19).
• Gender was not listed.
• Patients had Hodgkin disease (16), central nervous system (CNS) tumor (10), pediatric sarcoma (8), and neuroblastoma (6).
• Average total radiation dose was 34.3 Gy (range 25.2–67 Gy). 
• Daily fractionation ranged from 1.5 to 1.8 Gy.

St. Jude Children’s Research Hospital, Memphis, Tennessee

The study used a quasiexperimental design. Patients served as their own controls.

The primary endpoint was skin care failure, which included moderate to severe dryness, pruritus, erythema, and dry desquamation. Skin comfort assessment was completed by the patient or his/her parent and consisted of 15 items on a four-level scale. Dermatologic assessment included a questionnaire of negative items and was completed by nursing staff. The National Cancer Institute (NCI) Common Terminology Criteria (CTC) for adverse events involving the skin used a grade 1 to 5 scale.

Significant differences in specific variables favoring APP cream were noted in some patients, including:

• Skin comfort variables: dry (p = 0.002), soft (p = 0.057), feels good (p = 0.002), rough (p = 0.065), and smooth (p = 0.012)
• Dermatologic variables: dryness (p = 0.013), erythema (p = 0.002), and peely (p = 0.008).

Grouped CTC scores were supportive of APP cream (p = 0.004). In comparing first and last assessments, two dermatologic variables, dryness (p = 0.035) and peely (p = 0.016), favored APP cream. During RT, there was a difference in CTC scores, favoring the cream (p = 0.004). 

APP cream is more effective than aloe vera–based gel for the prevention and treatment of radiodermatitis.

• This was a study on pediatric patients; applicability to adult patients has not been studied.
• The study lacked a control group to enable determination of actual effectiveness of either product independently.
• The study had a small sample size.