A Single-Blind, Randomized Controlled Trial of Sanyrene — A Complex of Linoleic Acid and Vitamin E for Prophylaxis of Radiation Dermatitis in Patients with Breast and Head Neck Cancer

Abstract

<h3>Purpose/Objective(s)</h3> Radiation dermatitis (RD) is a common side effect of radiation therapy (RT). The severity of RD is significantly associated with patients' quality of life (QOL), even negatively affect anticancer efficacy. There is still a lack of consensus on RD prophylaxis and management. Serveal studies reported linoleic acid could reduce incidence rate of skin injury from ultraviolet ray. Here, we investigate the effects of Sanyrene-a complex of linoleic acid and vitamin E versus Vitamin E on RD in patients with breast cancer and head neck cancer receiving radical radiotherapy (≥50Gy). <h3>Materials/Methods</h3> A prospective single-blind, randomized controlled trial was conducted. Patients either received Sanyrene or Vitamin E (usual care). Patients were randomly assigned in 1:1 ratio to receive Sanyrene and Vitamin E. All drugs were topically applied on the area of skin being irradiated at the onset of radiotherapy, twice a day up to 2 weeks post treatment. Radiation therapy oncology group (RTOG) for skin toxicity score and dermatitis-related QOL scale were used to evaluate skin toxicity, pain and skin-related quality of life. The primary endpoint was incidence rate of ≥grade 2 skin toxicity. Secondary endpoint was dermatitis-related QOL. (Trial Registration: ChiCTR2100050910) <h3>Results</h3> A total of 102 patients were randomized in this study. At the end of radiation treatment, Sanyrene arm had a lower percentage of grade 2 (59.2%) and grade 3 (28.7%) skin toxicity compared with Vitamin E arm (84.3% and 41.1%, respectively) (P<0.001). The incidence rate of ≥grade 2 skin toxicity were 2% and 41.9% in Sanyrene arm and 8.2% and 88.8% in Vitamin E arm at day 25 and day 50 during radiation course (HR:0.67, 95%CI:0.472-0.861, P=0.018). Moreover, patients receiving Sanyrene had a 29.4% reduced risk of developing ≥grade 1 skin toxicity throughout treatment compared to Vitamin E arm (HR:0.706, 95%CI:0.581-0.897, P=0.037). Patients in Sanyrene arm reported better scores of dermatitis-related QOL compared to Vitamin E arm at the end of treatment (8.3 vs.25, P=0.013) and 2 weeks post treatment (1.0 vs.22.9, P<0.001). No treatment interruptions and adverse events related to study products were reported in either arm. <h3>Conclusion</h3> Sanyrene is effective for preventing, and delaying the development of any grade skin toxicity. Meanwhile, patients receiving Sanyrene have better dermatitis-related QOL at the end of radiation course.