Using EGCG inhalation to treat interstitial pneumonia in cancer patients
Oxygen Atomizing Inhalation of EGCG in the Treatment Interstitial Pneumonia in Cancer Patients: Phase I-II Clinical Trial
This study is testing if inhaling a green tea compound called EGCG can help cancer patients with interstitial pneumonia feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shandong Cancer Hospital and Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05758571 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of epigallocatechin-3-gallate (EGCG), a compound found in green tea, on interstitial pneumonia in patients with malignant tumors. The study is divided into two phases: Phase I focuses on determining the safety and appropriate dosing of EGCG through a dose-escalation approach, while Phase II evaluates the efficacy of EGCG compared to a placebo in a randomized controlled setting. Participants will be assessed through both clinician evaluations and self-reports to gauge the treatment's effectiveness. The trial aims to explore the potential of EGCG in alleviating pneumonia symptoms in cancer patients, particularly those affected by COVID-19.
Who should consider this trial
Good fit: Ideal candidates include cancer patients diagnosed with malignant tumors who also have moderate pneumonia related to COVID-19.
Not a fit: Patients with rapidly progressing critical illness due to COVID-19 or pneumonia caused by other pathogens may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for cancer patients suffering from interstitial pneumonia.
How similar studies have performed: While the use of EGCG has shown promise in preclinical studies, this specific application for interstitial pneumonia in cancer patients is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed malignant tumors by pathology or cytology * COVID-19 with a confirmed positive polymerase chain reaction or antigen test result for SARS-CoV-23 * Moderate pneumonia, according to the diagnosis and treatment standard of COVID-19 in Peking Union Medical College Hospital * Pulmonary function of the patient can be treated with aerosol inhalation for 5-7 days Exclusion Criteria: * Current or recent progresses rapidly and may develop into a Critical illness with coronavirus in a short period of time * Caused by other viruses such as cytomegalovirus, as well as pneumocystis pneumonia, pulmonary edema, aspiration pneumonia and acute interstitial pneumonia * Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation * Need systemic use of immune suppressive agents
Where this trial is running
Jinan, Shandong
- Shandong Cancer Hospital — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Ligang Xing, MD,PhD
- Email: zhx87520052@163.com
- Phone: 86-531-67626996
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.