UnknownPhase 2

Study of Epigallocatechin-3-gallate (EGCG) for Esophagus Protection in Patients With Lung Cancer Receiving Radial Radiotherapy

83 participantsStarted 2015-04

Plain-language summary

The investigators conducted this phase II study of EGCG therapy protection of the esophagus from damage induced by radiotherapy. In order to observe the effectiveness of EGCG, esophageal toxicity was recorded weekly using a grading scale based on symptomatology, following the Radiation Therapy Oncology Group (RTOG) scoring system. Patient-reported pain related to esophagitis was measured using the numerical rating scale (NRS) every week from EGCG application to 2 weeks after the end of radiotherapy. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * pathologically documented LC * considered medically inoperable stage IIIA or stage IIIB or limited stage small cell lung cancer * age ≥18 years * Karnofsky ≥70 * adequate hematologic, hepatic and renal function * FEV1 \> 800 cc * mean esophagus dose \>20 Gy Exclusion criteria were as follows: * a known allergy or hypersensitivity to EGCG * pregnancy or lactation * prior radiation to the thorax

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Superiority of EGCG in reducing Grade II esophagitis as assessed by RTOG scores in patients with lung cancer receiving radiation

Timeframe: Each patient will be enrolled for a 8-9 week trial

Trial details

NCT IDNCT02577393

SponsorShandong Cancer Hospital and Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06

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