Effect of Recombinant Human Epidermal Growth Factor on Skin Reaction Induced by Radiation in Rectal and anal Cancer Patients: A Self-Controlled Study

Abstract Backgtound: Recombinant human epidermal growth factor (rhEGF) was reported to be beneficial for radiation induced skin injury (RISR), however, whether it is useful in patients with rectal and anal cancers are rarely reported. High-level evidence about this is even more lacking. Objective The purpose of this study was to provide high-level evidence for the application of rhEGF for skin protection in rectal and anal cancer patients during radiotherapy and to analyze the factors associated with RISR. Methods Patients were prospectively enrolled from January 2019 to December 2020. The pelvic skin area receiving radiotherapy was randomly assigned to the experimental and control side by the midline. Self-controls were formed on both sides.The experimental side was sprayed with rhEGF, while the control side was sprayed with physiological saline. The grading of RISR on two sides were assessed. At the end of radiotherapy, the area of RISR was evaluated. Factors associated with RISR were analyzed. Results Totally,193 patients were enrolled. At the end of radiotherapy, between the two groups, there was not a significant difference referring to grading. while there was a difference in dermatitis area. Tumor distance from the anal edge ≤ 4cm, without colostomy, the biological effective dose of radiotherapy > 60Gy are all adverse factors affecting the area of RISR in radiotherapy. Conclusions rhEGF can protect the skin receiving radiotherapy in rectal and anal patients. trial registration number: This clinical trial has been registered in China’s Clinical trials Network ((registration time: 2019.01.20; registration number: ChiCTR1900020842).