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A prospective phase II trial of EGCG for treatment of acute radiation-induced intestinal injury

A prospective phase II trial of EGCG for treatment of acute radiation-induced intestinal injury

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053703
Enrollment
Unknown
Registered
2021-11-27
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

radiation-induced intestinal injury

Interventions

Experimental group:Oral EGCG (400mg daily)

Sponsors

The Second Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Cervical cancer patients with pathological diagnosis and admitted to our department for radical radiotherapy or postoperative adjuvant radiotherapy; 3. The patient's hematopoietic function and general condition are acceptable (leukocytes > 2.5 x 10^9/L, platelets > 50 x 10^9/L, bilirubin does not exceed 1.5 times the upper limit of normal, and liver function alanine aminotransferase and aspartate aminotransferase do not exceed normal. 2.5 times the upper limit, renal function creatinine does not exceed 1.5 times the upper limit of normal); 4. No congestive heart failure, unstable angina, or unstable arrhythmia occurred within the past 6 months; 5. The patient activity status score is 0-1 points according to the Eastern Cooperative Oncology Group (ECOG) scoring method, the Karnofsky (KPS) scoring method evaluates the functional status >= 70 points, and the life expectancy assessment is more than 3 points. moon; 6. Be able to comply with the protocol during the study period; 7. Sign written consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women; 2. There is a history of tumor, chemotherapy, and radiotherapy, except for cured skin cancer; 3. Those who have a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the clinical severity of which may hinder the signing of informed consent or affect the patient's compliance with drug treatment according to the investigator's judgment; 4. Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more congestive heart failure or severe arrhythmia requiring pharmacological intervention, or recent History of myocardial infarction within 12 months; 5. Those who need immunosuppressive therapy for organ transplantation; 6. Known major active infection, or the investigator judges that there is a major blood, kidney, metabolic, gastrointestinal, endocrine function or metabolic disorder, or other serious uncontrolled concomitant diseases; 7. Other circumstances that the researcher deems unsuitable for inclusion; 8. Those who are allergic to any research drug ingredients; 9. Those with a history of immunodeficiency, including HIV test positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation, or those with other immune-related diseases requiring long-term oral hormone therapy; 10. Have a clear history of other important organ (system) diseases, intestinal diseases (inflammatory bowel disease, etc.) and urinary tract diseases; 11. Those who have received any of the following treatments within 4 weeks before stool sampling, including antibiotics, probiotics, prebiotics, hormones, immunosuppressants, etc.; 12. Received chemotherapy, targeted therapy, radiotherapy or immunotherapy within 2 weeks before stool sampling.

Design outcomes

Primary

MeasureTime frame
Incidence of radiation-induced intestinal injury;

Countries

China

Contacts

Public ContactCai Shang

The Second Affiliated Hospital of Soochow University

cbibbys@163.com+86 15962254350

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026