Stefanelli, A., Forte, L., Medoro, S., Sgualdo, A., Lombardo, D., Zini, G., . . . Fiorica, F. (2014). Topical use of phytotherapic cream (Capilen^® cream) to prevent radiodermatitis in breast cancer: A prospective historically controlled clinical study. Giornale Italiano Di Dermatologia e Venereologia: Organo Ufficiale, Societa Italiana Di Dermatologia e Sifilografia, 149, 107–113.

To determine whether a phytotherapeutic agent is effective for the prevention of radiodermatitis

Patients were entered into the study prospectively. Patients used the same modalities as historical controls for skin care and also Capilen^® cream. Patients were evaluated weekly and at four weeks after treatment concluded. The cream was applied twice daily beginning two weeks before radiation therapy (RT) and during RT. A topical steroid was used at the first sign of skin alterations (erythema) every day until skin returned to its baseline state. The experimental cream contained extracts form calendula and multiple other plants with antioxidative and anti-inflammatory properties.

• N = 30 (30 historical controls)
• MEAN AGE = 61.6 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Median dose of 50 Gy in 25 fractions to the whole breast; skin-sparing radiotherapy was planned

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

• PHASE OF CARE: Active antitumor treatment

Observational with historical controls

• Radiation Therapy Oncology Group (RTOG) skin toxicity scale

A larger proportion of experimental patients experienced no toxicity. Lower percentages of patients in the experimental group were seen with all toxicity grades. There was no statistically significant difference between groups in toxicity level distributions. The percentage of patients who were toxicity-free at the end of treatment was 53.3% in the experimental group and 36.7% in the historical controls (p = 0.041).

Fewer patients using physiotherapy cream had radiodermatitis at the end of study evaluations, suggesting that it may be useful for the prevention of radiodermatitis. As this study had several limitations, additional well designed research is warranted.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Other limitations/explanation: The skin care used by historical controls and included in the care of study patients is not described; it appears that a variety of other topical creams were used. As topical steroids were used at the first sign of erythema, it is not clear what effects the steroid had versus the experimental intervention.

The findings of this study suggested that the cream tested here might be useful; however, because of multiple study limitations, this evidence is not strong. Additional research is warranted as there are few interventions that have been effective in the prevention and management of radiodermatitis.