The Role and Intervention of TGF-β in Abdominal Radiation Injury

Radiotherapy Side Effect Clinical Trial

Official title:

The Role of TGF-β in Abdominal Radiation Injury and Taking Medicine to Block TGF-β for Protecting Normal Organization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03613506
• Other study ID #: HBCCS AB-01
• Status: Recruiting
• Phase: Phase 2
• Start date: October 25, 2019
• Est. completion date: December 25, 2022

Study information

• Verified date: January 2022
• Source: Wuhan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project aims to investigate the relationship between radiation-induced the relationship between elevated peripheral blood TGFβ and complications of radiotherapy,and to analysis of changes in peripheral blood TGFβ levels after abdominal radiotherapy and its relationship with radiotherapy complications.Simultaneously,Patients who underwent abdominal radiotherapy were given captopril (sustained release) to block TGFβ,Whether it can reduce peripheral blood TGFβ levels and reduce radiotherapy complications,to explore the protective effect of blocking TGFβ secretion on normal tissues after radiotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 226
• Est. completion date: December 25, 2022
• Est. primary completion date: June 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Informed consent form for this study has been signed

2. Age 18-70 years old, gender is not limited,Pathological diagnosis of patients with advanced malignant tumors,Radiotherapy indications;

3. BED (a/ß=10)=50;ECOG score 0-2;Blood routine:WBC=3.5×109/L,GRAN=2.0×109/L,Hb=90g/L,PLT=100×109/L;

4. Liver function: ALT or AST = 2.5 times the normal high value (ULN);Bilirubin = 1.5 × ULN, serum APK = 2.5 × ULN;

5. Renal function:Serum creatinine =1.5×ULN, and creatinine clearance =60ml/min

6. No organ transplant history

7. Women of childbearing age must undergo a urine pregnancy test within 7 days prior to initiation of treatment and the results are negative and not in lactation

8. Male and female patients of childbearing age agreed to adopt a reliable method of contraception before entering the trial and during the study until 30 days after stopping the drug.

Exclusion Criteria:

1. Patients undergoing chemotherapy or targeted therapy at the same time

2. Long-term use of ACEI or ARB drugs for hypertension

3. This radiotherapy site has been treated with radiotherapy;Combined with severe heart disease or major organ failure

4. Have a history of drug abuse or alcohol addiction

5. Combined active infection

6. Combined with severe malnutrition or severe anemia

7. Human immunodeficiency virus (HIV) infection

8. During pregnancy or lactation

9. Those who are unable to tolerate or may be allergic to the drugs used in this study;Persons without civil capacity or limited capacity for civil conduct;

10. Researchers believe that it is not suitable for inclusion

Related Conditions & MeSH terms

• Radiation Injuries
• Radiotherapy Side Effect
• Taking Captopril

Intervention

Drug:
• Captopril 12.5 Mg
Taking captopril 12.5mg b.i.d for two months before radiotherapy.

Locations

Country	Name	City	State
China	Jin Peng	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study the effect of abdominal radiation therapy on peripheral blood TGFß levels	The levels of TGF-ß in peripheral blood of patients before and after radiotherapy were compared.	12 weeks
Primary	Blocking TGFß for protective effect on normal tissues	Give two groups of patients captopril (sustained release) 12.5mg b.i.d. for two months,comparing their levels of TGF-ß in peripheral blood	12 weeks