Efficacy of Epigallocatechin-3-Gallate in Preventing Dermatitis in Patients With Breast Cancer Receiving Postoperative Radiotherapy

Abstract

IMPORTANCE Safe and effective prophylactic therapies for radiation-induced dermatitis (RID) remain an unmet need.OBJECTIVE To determine if epigallocatechin-3-gallate (EGCG) solution reduces the incidence of RID in patients undergoing radiotherapy after breast cancer surgery. DESIGN, SETTING, AND PARTICIPANTSThis phase 2 double-blind, placebo-controlled randomized clinical trial enrolled 180 patients with breast cancer receiving postoperative radiotherapy at Shandong Cancer Hospital and Institute in Shandong, China, between November 2014 and June 2019. Data analysis was performed from September 2019 to January 2020.INTERVENTIONS Participants were randomly assigned (2:1) to receive either EGCG solution (660 μmol/L) or placebo (0.9% NaCl saline) sprayed to the whole radiation field from day 1 of the radiation until 2 weeks after radiation completion. MAIN OUTCOMES AND MEASURESThe primary end point was incidence of grade 2 or worse RID, defined by the Radiation Therapy Oncology Group scale. The secondary end points included RID index (RIDI), symptom index, changes in the skin temperature measured by infrared thermal images, and safety.RESULTS A total of 180 eligible patients were enrolled, of whom 165 (EGCG, n = 111; placebo, n = 54) were evaluable for efficacy (median [range] age, 46 [26-67] years). The occurrence of grade 2 or worse RID was significantly lower (50.5%; 95% CI, 41.2%-59.8%) in the EGCG group than in the placebo group (72.2%; 95% CI, 60.3%-84.1%) (P = .008). The mean RIDI in the EGCG group was significantly lower than that in the placebo group. Furthermore, symptom indexes were significantly lower in patients receiving EGCG. Four patients (3.6%) had adverse events related to the EGCG treatment, including grade 1 pricking skin sensation (3 [2.7%]) and pruritus (1 [0.9%]). CONCLUSIONS AND RELEVANCEIn this randomized clinical trial, prophylactic use of EGCG solution significantly reduced the incidence and severity of RID in patients receiving adjuvant radiotherapy for breast cancer. It has the potential to become a new choice of skin care for patients receiving radiotherapy.

Natural biomolecules and derivatives as anticancer immunomodulatory agents

“…It alleviated acute radiation-induced esophagitis in advanced, unresectable lung ( 114 ) and in esophageal cancer patients ( 115 ). Similar results were observed for post-resection radiotherapy-induced dermatitis in breast cancer patients ( 116 ). EGCG mouthwash reduced radiation-induced oral mucosal injury in radiotherapy-treated head and neck cancer patients in phase I ( 117 ).…”

“…It alleviated acute radiation-induced esophagitis in advanced, unresectable lung (114) and in esophageal cancer patients (115). Similar results were observed for post-resection radiotherapy-induced dermatitis in breast cancer patients (116).…”

The Potential of Flavonoids and Flavonoid Metabolites in the Treatment of Neurodegenerative Pathology in Disorders of Cognitive Decline

“…A significant number of clinical trials have been conducted on the EGCG polyphenolic flavonoid component of green tea. An examination of a selection of these trials [ 265 , 276 , 277 , 278 , 279 , 280 , 281 , 282 , 283 , 284 , 285 ] amply demonstrate the diverse biological properties of EGCG and its potential therapeutic applications. EGCG can potentially improve cognition in children with Down syndrome [ 276 ].…”

Resveratrol, Epigallocatechin Gallate and Curcumin for Cancer Therapy: Challenges from Their Pro-Apoptotic Properties

“…A phase I clinical trial with EGCG and standard chemotherapy (etoposide and cisplatin) and thoracic radiotherapy in unresectable stage III non-small cell lung cancer showed that oral administration of EGCG is safe and effective and suggested that it could be act as radioprotector without affecting the efficacy of radiation [ 169 ]. Moreover, a recent randomized clinical trial confirmed that EGCG solution use significantly reduced the incidence and severity of radiation-induced dermatitis in patients undergoing adjuvant radiotherapy for breast cancer [ 170 ]. However, other human clinical trials are still required to establish the efficacy of EGCG in the treatment of cancer.…”