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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Radiotherapy Side Effect; Taking Captopril
• Intervention / Treatment: Drug: Captopril 12.5 Mg

• Study Type: Interventional
• Enrollment (Anticipated): 226
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Recruiting
      • Jin Peng
      • Contact: Jin Peng; Phone Number: 13971235235; Email: pjxp888@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 (α/β=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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peripheral blood TGF-β content before and after radiotherapy	Drug: Captopril 12.5 Mg; Taking captopril 12.5mg b.i.d for two months before radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study the effect of abdominal radiation therapy on peripheral blood TGFβ levels	The levels of TGF-β in peripheral blood of patients before and after radiotherapy were compared.	12 weeks
Blocking TGFβ 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-β in peripheral blood	12 weeks

Collaborators and Investigators

• Sponsor: Wuhan University

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2019
• Primary Completion (Anticipated): June 25, 2022
• Study Completion (Anticipated): December 25, 2022

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: January 29, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Radiation Injuries; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Captopril
• Other Study ID Numbers: HBCCS AB-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No