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

• Status: Enrolling by invitation
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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 .

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Cancer Hospital and Institute

Criteria

Inclusion Criteria:

• ≥18 years old

• with histologically proven cancer

• receive external radiotherapy or concurrent chemoradiotherapy

Exclusion Criteria:

• previous radiotherapy

• previous chemotherapy for another neoplasia

• pregnancy or lactation

• a known allergy or hypersensitivity to EGCG