drugset / Trial / NCT01481818

Study of Topically Applied Green Tea Extract for Radio Dermatitis and Radiation Mucositis

NCT01481818 ↗

Phase 1/2 Unknown 15 enrolled Shandong Cancer Hospital and Institute
NaSingle-groupOpen-labelPrevention

Summary

Radiodermatitis and radiation mucositis were the most frequent side-effect during the course of radiotherapy, especially when concurrent chemoradiotherapy applied. Since reactive oxygen species formed upon radiation therapy play a central role in initiating and driving the detrimental signaling events, antioxidant supplementation is thought to provide a photoprotective effect against radiation. Green tea extract has been shown to have antioxidant and anti-inflammatory effects on various types of cells. To evaluate the safety and efficiency of green tea extract in the treatment of radio dermatitis and radiation mucositis, the investigators conducted this phase Ⅰ,II study using topical EGCG in cancer patients receiving radiotherapy or concurrent chemoradiotherapy .

Timeline

Start
2011-09
Primary completion
2022-06
Completion
2022-08

Drugs

EvaluationDrugModalityDoseRoute
Subject epigallocatechin-3-gallate Unknown 0.05 ml Topical