Shukla, P.N., Gairola, M., Mohanti, B.K., & Rath, G.K. (2006). Prophylactic beclomethasone spray to the skin during postoperative radiotherapy of carcinoma breast: A prospective randomized study. Indian Journal of Cancer, 43, 180–184.

DOI Link

Study Purpose

To determine the difference in occurrence of wet desquamation on axillary skin with use of beclomethasone dipropionate spray

Intervention Characteristics/Basic Study Process

Study participants were randomized to two groups. One group received beclomethasone dipropionate spray on irradiated axilla (200 mcg) seven days a week from day one of radiation therapy. Steroid spray was stopped after development of wet desquamation. The other group was not allowed to apply anything in the irradiated area. Both groups were instructed against using soap, oil, or cream in treatment area; shaving in the irradiated area; and wearing anything other than loose cotton clothing. A clinical examination was done weekly while on treatment.

Sample Characteristics

  • The study sample (N = 60) was comprised of patients with breast cancer who were receiving loco-regional radiation therapy to the axilla.
  • Median age of the steriod group (n = 30) was 44.6 years, with a range of 28–60 years. Median age of the control group (n = 30)  was 45.9 years, with a range of 29–60 years.
  • ER/PR-positive patients were started on tamoxifen 20 mg daily.

Study Design

The study used a randomized controlled trial design.

Measurement Instruments/Methods

  • Radiation-induced skin reaction was graded weekly in terms of erythema, dry desquamation, and wet desquamation until the end of prescribed 50 Gy dose and one month after completion of radiation therapy. Specific method of measurement not reported.
  • Chi-square test was used to see the statistical significance of the difference in wet desquamation on the axillary skin between two arms of the study.

Results

Wet desquamation of axillary skin at the end of radiation developed in 13.33% of patients in the steroid group and 36.66% of patients in the control group (p = 0.0369). There was no significant difference in median dose of radiation causing wet desquamation (42 versus 43.54 Gy).

Conclusions

Topical steroid (beclomethasone dipropionate spray) for skin during radiation may reduce risk of wet desquamation of the skin.

 

Limitations

  • No specific grading scale appears to have been used.
  • No inter- rater reliability testing done.
  • Patients were treated on a telecolbalt unit. A 6 MV photon unit has better skin sparing properties. The d-max of a telecolbalt unit is 5 mm versus 15 mm in a 6 MV photon unit. Findings may not be as applicable to 6 MV photon treatment units.
  • Patient compliance with skincare instructions were not discussed.
  • The sample size was small, with less than 100 patients.