Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

All Conditions

Infections

Respiratory Aspiration

Pneumonia

Lung Diseases

Lung Diseases, Interstitial

Communicable Diseases

Respiratory Tract Infections

Respiratory Tract Diseases

Antineoplastic Agents

Neuroprotective Agents

All Drugs and Chemicals

Flavonoid

Epigallocatechin gallate

Epigallocatechin

Epigallocatechin-3-gallate (EGCG) (high pressure liquid chromatographic purity ≥ 95%; from Ningbo Hepu Biotechnology Co., Ltd.) is dissolved in 0.9% normal saline; 10ml is inhaled by atomization three times a day. From the beginning of the diagnosis and 7 days after the signing of the informed consent form, the medication can be continued according to the wishes of the patients, but the total medication time is not more than 14 days.

EGCG (high pressure liquid chromatographic purity ≥ 95%; from Ningbo Hepu Biotechnology Co., Ltd.) is dissolved in 0.9% normal saline; 10ml is inhaled by atomization three times a day.

EGCG

Ligang Xing, MD,PhD

Hanxi Zhao, MD

Ligang Xing, MD, PhD

Epigallocatechin-3-gallate (EGCG) is a major polyphenol of green tea that possesses a wide variety of actions, such as anti-inflammatory, anti-fibrotic, pro-apoptotic, anti-tumorous, and metabolic effects via modulation of a variety of intracellular signaling cascades. In addition, preclinical studies have also emphasized the antiviral activity of epigallocatechin-3-gallate (EGCG), including SARS-CoV-2.

In previous studies, we found that EGCG can prevent and cure radiation-induced normal tissue damage in tumor patients. In clinical studies, we found that EGCG can prevent and treat radiation-induced acute radiation esophagitis, acute radiation skin injury, acute radiation oral mucositis with high safety. Thus, we designed this phase I-II clinical study in order to investigate the possible role of EGCG in the treatment interstitial pneumonia in tumor patients.

In this phase I study, subjects were divided into four dose groups according to the improved Fibonacci method and were given different doses of EGCG to evaluate adverse events. At the same time, the researchers conducted a phase II study of EGCG in tumor patients with interstitial pneumonia. The Phase II study was conducted with a randomized, controlled, placebo dose determined by Phase I. the subjects were divided into two groups (experimental group and placebo group). To observe the effectiveness of EGCG, the researchers will use both clinician assessment and patient self-assessment.

Oxygen Atomizing Inhalation of EGCG in the Treatment Interstitial Pneumonia in Cancer Patients

Oxygen Atomizing Inhalation of EGCG in the Treatment Interstitial Pneumonia in Cancer Patients: Phase I-II Clinical Trial

CTCAE v4.0 is an international standard for evaluating adverse event to cancer treatment.

The changes of lung before and after treatment were judged by CT chest with or without contrast.

Shandong Cancer Hospital and Institute

Principal investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Heart and Blood Diseases

Immune System Diseases

Neoplasms

Blood and Lymph Conditions

Nervous System Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Syndrome

Acute Kidney Injury

Fatigue

Renal Insufficiency

Depression

Heart Failure

Hypersensitivity

Multiple Myeloma

Neoplasms, Plasma Cell

Arrhythmias, Cardiac

Peripheral Nervous System Diseases

Jaundice

Vertigo

Dizziness

Sleepiness

Thromboembolism

Confusion

Tumor Lysis Syndrome

Teratogenesis

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Acute Graft Versus Host Disease

Pomalidomide

Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.

Jinshu Cho

1. Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form of the surveillance will be completed at the time when the planned number of patients to be enrolled is reached. During a period until conditions for approval are removed, a system enabling to retrospectively collect appropriate information based on patient data from RevMate® will be, as necessary, maintained.
2. Planned duration of the surveillance Anticipated to be 2 years and 6 months from the start date of release of Pomalyst

A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg

Pomalyst®Capsules Special Use-results Surveillance (All-case Surveillance)

Number of participants with adverse events

Celgene

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Oxygen Atomizing Inhalation of EGCG in the Treatment Interstitial Pneumonia in Cancer Patients	NCT05758571	Interstitial Pn... Neoplasms Malig...	EGCG	18 Years - 75 Years	Shandong Cancer Hospital and Institute
A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg	NCT02921828	Multiple Myelom...		18 Years -	Celgene

Spots Global Cancer Trial Database for interstitial pneumonia