Study of Topically Applied Green Tea Extract for Radio Dermatitis and Radiation Mucositis
Phase Ⅰ,ⅡStudy of Topically Applied Green Tea Extract for Prevention and Treatment of Radio Dermatitis and Radiation Mucositis
1 other identifier
interventional
15
0 countries
N/A
Brief 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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2011
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 23, 2011
CompletedFirst Posted
Study publicly available on registry
November 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedApril 28, 2020
April 1, 2020
10.8 years
November 23, 2011
April 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with Adverse Events
participants will be followed for the duration of radiotherapy, an expected average of 6 weeks").
Secondary Outcomes (1)
Frequency and Severity of Radio Dermatitis or Radiation Mucositis during Radiotherapy
participants will be followed every weeks for the duration of radiotherapy, an expected average of 6 weeks").
Study Arms (1)
radioprotector
EXPERIMENTALInterventions
Apply about 0.05ml/cm2 EGCG with different concentration topically for 3 times a day during radiotherapy
Eligibility Criteria
You may qualify if:
- ≥18 years old
- with histologically proven cancer
- receive external radiotherapy or concurrent chemoradiotherapy
You may not qualify if:
- previous radiotherapy
- previous chemotherapy for another neoplasia
- pregnancy or lactation
- a known allergy or hypersensitivity to EGCG
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Zhao H, Zhu W, Xie P, Li H, Zhang X, Sun X, Yu J, Xing L. A phase I study of concurrent chemotherapy and thoracic radiotherapy with oral epigallocatechin-3-gallate protection in patients with locally advanced stage III non-small-cell lung cancer. Radiother Oncol. 2014 Jan;110(1):132-6. doi: 10.1016/j.radonc.2013.10.014. Epub 2014 Jan 17.
PMID: 24444526DERIVED
Study Officials
- STUDY DIRECTOR
Jinming Yu, M.D.
Shandong Cancer Hospital and Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
November 23, 2011
First Posted
November 30, 2011
Study Start
September 1, 2011
Primary Completion
June 1, 2022
Study Completion
August 1, 2022
Last Updated
April 28, 2020
Record last verified: 2020-04