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

NCT01481818 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-04-28

No results posted yet for this study

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 .

Conditions

  • Epigallocatechin Gallate
  • Radio Dermatitis
  • Radiation Mucositis

Interventions

DRUG

EGCG

Apply about 0.05ml/cm2 EGCG with different concentration topically for 3 times a day during radiotherapy

Sponsors & Collaborators

  • Shandong Cancer Hospital and Institute

    lead OTHER

Principal Investigators

  • Jinming Yu, M.D. · Shandong Cancer Hospital and Institute

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2022-06-30
Completion
2022-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01481818 on ClinicalTrials.gov