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Randomized Controlled Trial
. 2020 Jan-Feb;34(1):413-422.
doi: 10.21873/invivo.11790.

Reducing Radiation Dermatitis Using a Film-forming Silicone Gel During Breast Radiotherapy: A Pilot Randomized-controlled Trial

Songmi Ahn  1 , Kihoon Sung  2 , Hyun Ju Kim  1 , Young Eun Choi  1 , Young Kyu Lee  1 , Jeong Soo Kim  3 , Seul Ki Lee  3 , Joo-Young Roh  3
Affiliations
Randomized Controlled Trial

Reducing Radiation Dermatitis Using a Film-forming Silicone Gel During Breast Radiotherapy: A Pilot Randomized-controlled Trial

Songmi Ahn et al. In Vivo. 2020 Jan-Feb.

Abstract

Background/aim: To evaluate whether topical use of a film-forming silicone gel (StrataXRT®) could reduce radiation dermatitis compared to a moisturizing cream (X-derm®) in patients receiving whole breast radiotherapy.

Patients and methods: A total of 56 patients with breast cancer were randomized to use StrataXRT or X-derm. The severity of radiation dermatitis was graded using physiological skin parameters, clinician-assessed visual rating scales and patient-reported symptoms. Changes in these parameters from baseline to 4 weeks post-radiotherapy were evaluated every two weeks.

Results: Two-way repeated-measures ANOVA revealed different patterns of changes in the erythema index (F=3.609, p=0.008) and melanin index (F=3.475, p=0.015). The post hoc analysis demonstrated a significantly lower erythema index and melanin index in the patients allocated to the StrataXRT group.

Conclusion: The use of StrataXRT can reduce radiation dermatitis with respect to objectively measured physiological skin parameters. The results of the present study will support the feasibility of conducting a larger randomized controlled trial.

Keywords: Film-forming silicone gel; StrataXRT; breast cancer; radiation dermatitis.

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Conflict of interest statement

The Authors declare that they have no competing interests regarding this study.

Figures

Figure 1
Figure 1. CONSORT flow diagram showing participant flow through each stage of the randomized controlled trial (enrolment, intervention allocation, follow-up, and data analysis).
Figure 2
Figure 2. Changes in the severity of radiation dermatitis in the Silicone group (StrataXRT®) and the Moisturizer group (X-derm®). Data are expressed as means (95% confidence intervals). Two-way repeated measures ANOVA with Greenhouse–Geisser correction followed by Bonferroni’s post hoc test were used to verify the statistical significance of interaction between time and group factors, which were expressed as F-statistic and p-value. A: Erythema index (arbitrary Mexameter® units on a scale from 0 to 999). B: Melanin index (arbitrary Mexameter® units on a scale from 0 to 999). C: Trans-epidermal water loss (TEWL, g/h/m2). D: Modified 10-point Catterall skin scoring profile. E: Radiation Therapy Oncology Group (RTOG) criteria. F: Common Terminology Criteria for Adverse Events. G: Dryness. H: Itching. I: Burning sensation. J: Pain. *p<0.0083, Bonferroni’s post hoc test for multiple comparisons.
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