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

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ClinicalTrials.gov Identifier: NCT02577393
Recruitment Status : Enrolling by invitation
First Posted : October 16, 2015
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Han Xi Zhao, Shandong Cancer Hospital and Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Neoplasms Esophagitis Prevention & Control Epigallocatechin Gallate Drug: EGCG Drug: mLDG Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Actual Study Start Date : April 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: prophylactic EGCG group Drug: EGCG
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.

Experimental: therapeutic EGCG group Drug: EGCG
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.

Placebo Comparator: conventional therapy group Drug: mLDG
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577393


Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Investigators
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Study Chair: Ligang Xing, MD,PhD Shandong Cancer Hospital and Institute

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Responsible Party: Han Xi Zhao, Principal Investigator, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT02577393     History of Changes
Other Study ID Numbers: GTEEC-2015
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Keywords provided by Han Xi Zhao, Shandong Cancer Hospital and Institute:
Lung Neoplasms
esophagitis
Prevention & Control
Epigallocatechin Gallate
Additional relevant MeSH terms:
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Lung Neoplasms
Esophagitis
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents