Lung NeoplasmsPhase 2NCT02577393
Study of Epigallocatechin-3-gallate (EGCG) for Esophagus Protection in Patients With Lung Cancer Receiving Radial Radiotherapy
A Phase 2 study testing EGCG and mLDG in people with Lung Neoplasms and Esophagitis, run by Shandong Cancer Hospital and Institute.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Esophagitis, Prevention & Control
- What is being tested?
- EGCG and mLDG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- a known allergy or hypersensitivity to EGCG
- pregnancy or lactation
- prior radiation to the thorax
About this study
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.
- Being tested
- EGCG, mLDG
- Keywords
- Lung Neoplasms, esophagitis, Prevention & Control, Epigallocatechin Gallate
- Medical subject headings
- Lung Neoplasms, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGCGDrug
EGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution three times a day. A new batch is made up each time. For esophageal application, repeated swallowing of 10 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls. We choose a dose of 440 lmol/L as the recommended concentration for this study by referring to our previous phase I study. Immediately at the beginning of radiotherapy, the EGCG solution is given until two weeks after radiotherapy completed. Steroids, non-steroidal anti-inflammatory drugs, narcotics, local anesthetics, or other antibiotic/antifungal therapy are not given unless esophagitis progressed to grade 4.
EGCGDrug
EGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution three times a day. A new batch is made up each time. For esophageal application, repeated swallowing of 10 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls. We choose a dose of 440 lmol/L as the recommended concentration for this study by referring to our previous phase I study. Patients begin medications as soon as grade 1 esophagitis occurred during radiation according to the RTOG criterion.
mLDGDrug
mLDG (lidocaine 0.16mg/mL, dexamethasone 0.02mg/mL, and gentamycin 0.16mg/mL) dissolved in 0.9% saline solution was administered three times a day. Patients were given oral mLDG solution, and began medications as soon as grade 1 esophagitis occurred during radiation according to the RTOG criterion.
| Study group | Role | What they receive |
|---|---|---|
| prophylactic EGCG group | Experimental | Not described Receives: Drug: EGCG |
| therapeutic EGCG group | Experimental | Not described Receives: Drug: EGCG |
| conventional therapy group | Placebo comparator | Not described Receives: Drug: mLDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superiority of EGCG in reducing Grade II esophagitis as assessed by RTOG scores in patients with lung cancer receiving radiation
Measured: Each patient will be enrolled for a 8-9 week trial
Secondary outcomes (2)
Superiority of EGCG in decreasing the serum Inflammatory factors in patients with lung cancer receiving radiation
Measured: Each patient will be enrolled for a 8-9 week trial
Improved quality of life with usage of EGCG for treatment of radiation-esophagitis in patient with lung cancer.
Measured: Each patient will be enrolled for a 8-9 week trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Xi Zhao, Shandong Cancer Hospital and Institute
- Investigators
- Ligang Xing, MD,PhD, Study chair, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577393
- Sponsor's protocol ID
- GTEEC-2015
- Status last verified
- Apr 2020
- First submitted
- 28 Sep 2015
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Epigallocatechin-3-gallate (EGCG) for Esophagus Protection in Patients With Lung Cancer Receiving Radial Radiotherapy
- ClinicalTrials.gov ID
- NCT02577393
- Acronym / sponsor ID
- GTEEC-2015
- Keywords
- Lung Neoplasms, esophagitis, Prevention & Control, Epigallocatechin Gallate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| prophylactic EGCG group | Experimental | Drug: EGCG |
| therapeutic EGCG group | Experimental | Drug: EGCG |
| conventional therapy group | Placebo comparator | Drug: mLDG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- a known allergy or hypersensitivity to EGCG
- pregnancy or lactation
- prior radiation to the thorax
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGCGEGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution three times a day. A new batch is made up each time. For esophageal application, repeated swallowing of 10 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls. We choose a dose of 440 lmol/L as the recommended concentration for this study by referring to our previous phase I study. Immediately at the beginning of radiotherapy, the EGCG solution is given until two weeks after radiotherapy completed. Steroids, non-steroidal anti-inflammatory drugs, narcotics, local anesthetics, or other antibiotic/antifungal therapy are not given unless esophagitis progressed to grade 4. | Drug | prophylactic EGCG group |
| EGCGEGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution three times a day. A new batch is made up each time. For esophageal application, repeated swallowing of 10 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls. We choose a dose of 440 lmol/L as the recommended concentration for this study by referring to our previous phase I study. Patients begin medications as soon as grade 1 esophagitis occurred during radiation according to the RTOG criterion. | Drug | therapeutic EGCG group |
| mLDGmLDG (lidocaine 0.16mg/mL, dexamethasone 0.02mg/mL, and gentamycin 0.16mg/mL) dissolved in 0.9% saline solution was administered three times a day. Patients were given oral mLDG solution, and began medications as soon as grade 1 esophagitis occurred during radiation according to the RTOG criterion. | Drug | conventional therapy group |
Primary outcome
Superiority of EGCG in reducing Grade II esophagitis as assessed by RTOG scores in patients with lung cancer receiving radiation
Time frame: Each patient will be enrolled for a 8-9 week trial
2 secondary outcomes
Superiority of EGCG in decreasing the serum Inflammatory factors in patients with lung cancer receiving radiation
Time frame: Each patient will be enrolled for a 8-9 week trial
Improved quality of life with usage of EGCG for treatment of radiation-esophagitis in patient with lung cancer.
Time frame: Each patient will be enrolled for a 8-9 week trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
Related trials for Lung Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ligang Xing, MD,PhD study chair
Shandong Cancer Hospital and Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EGCG and mLDG in people with Lung Neoplasms and Esophagitis, run by Shandong Cancer Hospital and Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superiority of EGCG in reducing Grade II esophagitis as assessed by RTOG scores in patients with lung cancer receiving radiation (time frame: Each patient will be enrolled for a 8-9 week trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.