Document Type : Original Article


1 Breast Diseases Research Center, Shiraz University of Medical Sciences, Shiraz, Iran

2 Radiation Oncology Department, Shiraz University of Medical Sciences, Shiraz, Iran

3 Colorectal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran


Background: Breast cancer is among the most prevalent cancers in women. Radiotherapy is an important part in treatment of breast cancer, associated with some side-effects, including skin dermatitis. Dermatitis may be severe and impair quality of life. Multiple agents have been studied, but no standard treatment is yet available. Silicone based gel (StrataXRT) was promising in some studies in reducing skin inflammation and also radiotherapy-induced dermatitis.
Method: This was a randomized trial on 100 women with breast cancer who had undergone quadrantectomy for breast cancer. They received StrataXRT gel or best supportive care during radiotherapy. Dermatitis area and grade of dermatitis were measured.
Results: Regarding the mean size of radiation-induced dermatitis area, there was a significant difference between the intervention (36.88 cm2 ± 69.93) and control (83.83 cm2 ± 79.34) groups (P = 0.002). During radiotherapy, except in the fourth week, dermatitis was significantly more severe in the control group.
Conclusion: It seems that StrataXRT is helpful in decreasing radiotherapy-induced dermatitis.


How to cite this article:

Omidvari S, Eskandari Z, Nasrollahi H, Ahmadloo N, Ansari M, Hamedi SH, et al. The investigation of prophylactic effect of StrataXRT gel on radiation-induced dermatitis in breast cancer patients: a randomized clinical trial. Middle East J Cancer. 2022;13(2):293-8. doi: 10.30 476/mejc.2021.86775.1372.

1. Geara FB, Eid T, Zouain N, Thebian R, Andraos T,
Chehab C, et al. Randomized, prospective, open-label
phase III trial comparing mebo ointment with biafine
cream for the management of acute dermatitis during
radiotherapy for breast cancer. Am J Clin Oncol.
2018;41(12):1257-62. doi: 10.1097/COC.00000
2. Mosalaei A, Nasrolahi H, Shafizad A, Ahmadloo N,
Ansari M, Mosleh-Shirazi MA, et al. Effect of oral
zinc sulphate in prevention of radiation induced
oropharyngeal mucositis during and after radiotherapy
in patients with head and neck cancers. Middle East
J Cancer. 2010;1(2):69-76.
3. Ahmadloo N, Kadkhodaei B, Omidvari S, Mosalaei
A, Ansari M, Nasrollahi H, et al. Lack of prophylactic
effects of aloe vera gel on radiation induced dermatitis
in breast cancer patients. Asian Pac J Cancer Prev.
2017;18(4):1139-43. doi: 10.22034/APJCP.2017.
4. Salvo N, Barnes E, van Draanen J, Stacey E, Mitera
G, Breen D, et al. Prophylaxis and management of
acute radiation-induced skin reactions: a systematic
review of the literature. Curr Oncol. 2010;17(4):94-
112. doi: 10.3747/co.v17i4.493.
5. Chan RJ, Blades R, Jones L, Downer TR, Peet SC,
Button E, et al. A single-blind, randomised controlled
trial of StrataXRT(R) - A silicone-based film-forming
gel dressing for prophylaxis and management of
radiation dermatitis in patients with head and neck
cancer. Radiother Oncol. 2019;139:72-8. doi:
6. Ahn S, Sung K, Kim HJ, Choi YE, Lee YK, Kim JS,
et al. Reducing radiation dermatitis using a filmforming
silicone gel during breast radiotherapy: A
pilot randomized-controlled trial. In Vivo. 2020;34(1):
413-22. doi: 10.21873/invivo.11790
7. Ulff E, Maroti M, Serup J, Nilsson M, Falkmer U.
Prophylactic treatment with a potent corticosteroid
cream ameliorates radiodermatitis, independent of
radiation schedule: A randomized double blinded
study. Radiother Oncol. 2017;122(1):50-3. doi:
8. Pinnix C, Perkins GH, Strom EA, Tereffe W,
Woodward W, Oh JL, et al. Topical hyaluronic acid
vs. standard of care for the prevention of radiation
dermatitis after adjuvant radiotherapy for breast cancer:
single-blind randomized phase III clinical trial. Int J Radiat Oncol Biol Phys. 2012;83(4):1089-94. doi:
9. Gu J, Zhu S, Li X, Wu H, Li Y, Hua F. Effect of
amifostine in head and neck cancer patients treated
with radiotherapy: a systematic review and metaanalysis
based on randomized controlled trials. PLoS
One. 2014;9(5):e95968. doi: 10.1371/journal.pone.
10. Wells M, Macmillan M, Raab G, MacBride S, Bell
N, MacKinnon K, et al. Does aqueous or sucralfate
cream affect the severity of erythematous radiation
skin reactions? A randomised controlled trial. Radiother
Oncol. 2004;73(2):153-62. doi: 10.1371/journal.
11. Fisher J, Scott C, Stevens R, Marconi B, Champion
L, Freedman GM, et al. Randomized phase III study
comparing Best Supportive Care to Biafine as a
prophylactic agent for radiation-induced skin toxicity
for women undergoing breast irradiation: Radiation
Therapy Oncology Group (RTOG) 97-13. Int J Radiat
Oncol Biol Phys. 2000;48(5):1307-10. doi: 10.1016/