Hindley, A., Zain, Z., Wood, L., Whitehead, A., Sanneh, A., Barber, D., & Hornsby, R. (2014). Mometasone furoate cream reduces acute radiation dermatitis in patients receiving breast radiation therapy: Results of a randomized trial. International Journal of Radiation Oncology, Biology, Physics, 90, 748–755.

To demonstrate the potential benefits of topical mometasone furoate (MF) for the prevention of acute radiation reactions with a primary measure/endpoint being the mean modified Radiation Therapy Oncology Group (RTOG) score

• MF and diprobase were applied daily to the irradiated sites from day 1 for five weeks during breast radiation therapy (three weeks radiation therapy [RT], two weeks post-RT).

• Patients received 40 Gy of radiation therapy in 15 fractions in three weeks.
• Some patients received an electron boost of 10 Gy in five fractions.

• Assessments occurred at baseline and on days 8, 15, 21, 29, 36, and 43.

• N = 99
• MEAN AGE = 59.5 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All patients had breast cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: Included nonsmokers, ex-smokers, and smokers; bra cup sizes A–E were included; 72% also received chemotherapy

• SITE: Multi-site
• SETTING TYPE: Outpatient
• LOCATION: United Kingdom

• PHASE OF CARE: Active antitumor treatment

Double-blinded, randomized, controlled trial

• Modified RTOG for skin dermatitis
• Dermatology Life Quality Index (DLQI)
• Hospital Anxiety and Depression Scale (HADS)
• Erythema measurement by reflectance spectrophotometry

• Mean RTOG scores were lower for patients using MF than for those using diprobase (p = 0.046).
• Patients using MF experienced lower scores than those using diprobase for the time till maximum RTOG score (statistically insignificant).
• 4.8% of the patients using MF reached an RTOG of 2.5 versus the 15.5% of patients using diprobase who reached the same score. On a week-to-week basis, the difference in average scores between the groups in was not significantly different.
• The odds ratio of having a lower RTOG score associated with MF use was 2.38 (p = 0.18).

• Higher erythema values were seen in patients using diprobase versus MF. Over the course of the study period, the average treatment difference between groups was significantly better for those using MF (p = 0.012).

• Patients in the MF group experienced higher anxiety and depression scores at baseline than those in the diprobase group.

• Diprobase was associated with increased DLQI scores between weeks 2 and 3, but these scores gradually fell.
• MF was associated with increased DLQI scores till week 5, but this score fell thereafter.
• DLQI scores were worse for those using diprobase.

This study demonstrated that MF cream may be beneficial in reducing the severity of acute radiation skin reactions when compared to diprobase cream applied daily to the irradiated area on the breast during three weeks of RT and two weeks post-RT.

• Small sample (< 100)
• Baseline sample/group differences of import
• Measurement validity/reliability questionable
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%
• Other limitations/explanation: It is not clear whether intensity-modulated radiation therapy was used, which impacts the development of radiodermatitis. A slightly higher percentage of participants in the diprobase group also received chemotherapy, which could have affected the results in this group negatively. The chemotherapy agents that participants received were not described.

The findings of this study demonstrated that the use of MF cream was more effective than an aqueous cream for the prevention of severe radiodermatitis in women receiving radiation therapy for breast cancer. Mixed results have been seen in various studies using different topical corticosteroids, suggesting that specific steroid selection is important. Overall findings suggest that it may be important to begin topical treatment use prior to radiation rather than using steroids for the treatment of radiodermatitis after it has developed. The optimal schedule for the use of such treatments has not been determined, and it has varied across studies.