Meghrajani, C.F., Co, H.S., Arcillas, J.G., Maano, C.C., & Cupino, N.A. (2015). A randomized, double-blind trial on the use of 1% hydrocortisone cream for the prevention of acute radiation dermatitis. Expert Review of Clinical Pharmacology, 9, 483–491. 

To evaluate the efficacy of 1% hydrocortisone cream for the prevention of acute radiodermatitis

Patients were randomized to receive either 1% hydrocortisone or placebo cream. Patients were to apply the cream to the irradiated field twice daily beginning on the first day of radiation therapy until one week after the last radiation session. The cream was to be applied at least two hours prior to therapy. Patients were instructed not to use any other topical medications or deodorants during the study. In case of severe radiodermatitis, additional treatment was determined by the dermatologist. These patients were considered treatment failures and were included in the analysis. Patients were evaluated at one, two, three, four, and five weeks.

• N = 50
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Patients with breast cancer after modified radical mastectomy who had completed chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: The radiation dose was 50 Gy in 25 fractions five times weekly to the chest wall, surgical scar, and regional lymph nodes using a Cobalt 60 machine.

• SITE: Single site  
• SETTING TYPE: Outpatient    
• LOCATION: Philippines

PHASE OF CARE: Active antitumor treatment

• Double-blind, placebo-controlled, randomized, controlled trial

• National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
• Visual analog scale (VAS) for pruritus, burning, and pain
• Dermatology Life Quality Index (DLQI)

Four patients from each group developed moist desquamation by week 5. No difference existed between groups in preventing moist desquamation. At week 1, a higher incidence of grade 1 dermatitis was observed in the placebo group (p = 0.038), and at week 4, a higher occurrence of grade 2 dermatitis was observed in the placebo group (p = 0.017). Groups were comparable at weeks 3–5. The incidence of pruritus was less in the steroid group in weeks 4 and 5 (p < 0.04).

The findings suggest that the use of topical 1% hydrocortisone cream reduced pruritus and delayed the onset of radiation dermatitis. However, it did not prevent moist desquamation compared to the placebo.

• Key sample group differences that could influence results
• Significant differences were observed between groups in total field size irradiated.
• No information on differences between groups in breast size or skin folds in the field was provided.
• Use of Cobalt 60 versus IMRT

Topical steroid cream was associated with less pruritus from radiodermatitis and may delay the onset of skin problems; however, it was not effective in preventing severe skin toxicity. Whether stronger formulations would be more beneficial is unclear. Patients can benefit from the use of topical steroids to reduce itching.