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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prophylactic EGCG group | Experimental |
| |
| therapeutic EGCG group | Experimental |
| |
| conventional therapy group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGCG | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Superiority of EGCG in reducing Grade II esophagitis as assessed by RTOG scores in patients with lung cancer receiving radiation | Each patient will be enrolled for a 8-9 week trial |
| Measure | Description | Time Frame |
|---|---|---|
| Superiority of EGCG in decreasing the serum Inflammatory factors in patients with lung cancer receiving radiation | 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. |
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Inclusion Criteria:
Exclusion criteria were as follows:
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| Name | Affiliation | Role |
|---|---|---|
| Ligang Xing, MD,PhD | Shandong Cancer Hospital and Institute | Study Chair |
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|
| EGCG | Drug | 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. |
|
| mLDG | Drug | 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. |
|
| Each patient will be enrolled for a 8-9 week trial |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D004941 | Esophagitis |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
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