Boström, A., Lindman, H., Swartling, C., Berne, B., & Bergh, J. (2001). Potent corticosteroid cream (mometasone furoate) significantly reduces acute radiation dermatitis: Results from a double-blind, randomized study. Radiotherapy and Oncology, 59, 257–265.

DOI Link

Study Purpose

To determine if use of mometasone furoate (MMF), a corticosteroid cream could reduce intensity of erythema in acute radiation dermatitis

Intervention Characteristics/Basic Study Process

Patients were randomized to receive tubes of either MMF cream 0.1%  or an emollient cream as a placebo control. Patients were instructed to apply the cream on the irradiated area twice a week up to 24 Gy and then once daily for the rest of treatment and three weeks after completion of radiation therapy. All patients in both study groups also applied the emollient cream over the radiated area once daily throughout the entire study period.

Sample Characteristics

  • The study sample (N = 50) was comprised of female patients with breast cancer who had undergone breast-conserving surgery.
  • Mean age was 58 years for the MMF group and 60 years for the control group.
  • All had a World Health Organization performance status of 0.
  • A 5 MV photon beam was delivered in 2 Gy fractions for a total dose of 54 Gy.

Setting

The study took place in Uppsala, Sweden.

 

Study Design

The study used a randomized double-blind controlled design.

Measurement Instruments/Methods

  • Skin reaction was measured with a seven-point grading scale, from 0 (no reaction) to 6 (moist desquamation) evaluated in five defined skin regions at each visit. Maximum scores were used in analysis.
  • Patients’ subjective experiences of itching, burning, and pain were measured using a visual analogue scale.
  • The Mann Whitney U test was used for all statistical comparisons.
  • A reflectance spectrophotometer was used to rate erythema. The device emits various light colors corresponding to absorption peaks of hemoglobin and melanin.
  • The intensity of emitted light as measured by a photo detector was used to provide a patient erythema index and a patient melanin index. These indexes were calculated as the mean of three assessments in each of five skin regions identified for each patient.

Results

  • The two-photon excitation was lower in the MMF group (p = 0.033)
  • The maximal skin reaction grade was lower in the MMF treated group (p = 0.011).
  • Six patients in the control group required further topical treatment because of severe subjective symptoms. Three patients in the MMF group needed further treatment of severe moist desquamation in the axilla.
  • Patients in the MMF group reported less itching and burning, but the differences were not statistically significant.

Conclusions

MMF patients showed less pronounced erythema, less itching and less burning than emollient group. MMF may provide a benefit.

Limitations

  • The study had a small sample size, with less than 100 participants.
  • Reliability of the seven-point scale was not stated, and it was not clear who was making observations.
  • There was no log for application of the creams, so compliance with the planned regimen was not clear. The study did show that two patients did forget to apply the MMF during the treatment period.
  • The study did not report if other skin regimens, such as washing, were allowed.
  • Both groups applied the control emollient cream, so it is unclear what effect this had on skin reactions