Green Tea Derivative (–)-Epigallocatechin-3-Gallate (EGCG) for Prevention of Acute Radiation-Induced Intestinal Injury: A Prospective Phase II Clinical Study in Pelvic Cancer Patients

Abstract

Radiation-induced intestinal injury (RIII) remains the most common dose-limiting toxicity following radiotherapy (RT) for pelvic malignancies. However, few efficient and safe methods for the prevention of RIII are available in the clinical practice. Our previous study proved that the green tea polyphenol (-)-epigallocatechin-3-gallate (EGCG) efficiently attenuates radiation-induced intestinal injury (RIII) in animal level. Therefore, this prospective phase II clinical study (ChiCTR2100053703) evaluated the efficacy of EGCG in the prevention of RIII. Cervical or endometrial cancer patients who received adjuvant or radical RT in our department were enrolled, 400mg EGCG was taken daily, and RIII was evaluated weekly according to the RTOG criteria. Between February 2022 to January 2023, 37 patients were enrolled (30 were cervical cancer and the other 7 were endometrial cancer), and were followed-up regularly. Among them, the majority patients (75.7%, 28 patients) developed grade 0 or 1 RIII, for which no medical intervention was required. Meanwhile, the occurrence of grade 2 RIII was 24.3% (9 patients), which was significantly lower than that in the historical controls (usually 60% to 80%). Besides that, no patients developed grade 3 or worse RIII. In this phase II clinical trial, compared to historical controls, the prophylactic use of EGCG significantly reduced the incidence and severity of RIII in patients receiving pelvic RT. Therefore, EGCG has the potential to become a novel medical countermeasure for the prevention of RIII for pelvic cancer patients.