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

Primary Purpose

Radiotherapy Side Effect, Taking Captopril

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Captopril 12.5 Mg

About this trial

This is an interventional diagnostic trial for Radiotherapy Side Effect

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Informed consent form for this study has been signed
Age 18-70 years old, gender is not limited，Pathological diagnosis of patients with advanced malignant tumors，Radiotherapy indications；
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;
Liver function: ALT or AST ≤ 2.5 times the normal high value (ULN)；Bilirubin ≤ 1.5 × ULN, serum APK ≤ 2.5 × ULN;
Renal function：Serum creatinine ≤1.5×ULN, and creatinine clearance ≥60ml/min
No organ transplant history
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
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:

Patients undergoing chemotherapy or targeted therapy at the same time
Long-term use of ACEI or ARB drugs for hypertension
This radiotherapy site has been treated with radiotherapy；Combined with severe heart disease or major organ failure
Have a history of drug abuse or alcohol addiction
Combined active infection
Combined with severe malnutrition or severe anemia
Human immunodeficiency virus (HIV) infection
During pregnancy or lactation
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；
Researchers believe that it is not suitable for inclusion

Sites / Locations

Jin PengRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peripheral blood TGF-β content before and after radiotherapy

Arm Description

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03613506

First Posted

July 23, 2018

Last Updated

January 29, 2022

Sponsor

Wuhan University

1. Study Identification

Unique Protocol Identification Number

NCT03613506

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 25, 2019 (Actual)

Primary Completion Date

June 25, 2022 (Anticipated)

Study Completion Date

December 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wuhan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Radiotherapy Side Effect, Taking Captopril

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

226 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Peripheral blood TGF-β content before and after radiotherapy

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Captopril 12.5 Mg

Intervention Description

Taking captopril 12.5mg b.i.d for two months before radiotherapy.

Primary Outcome Measure Information:

Title

Study the effect of abdominal radiation therapy on peripheral blood TGFβ levels

Description

The levels of TGF-β in peripheral blood of patients before and after radiotherapy were compared.

Time Frame

12 weeks

Title

Blocking TGFβ for protective effect on normal tissues

Description

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

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Informed consent form for this study has been signed Age 18-70 years old, gender is not limited，Pathological diagnosis of patients with advanced malignant tumors，Radiotherapy indications； 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; Liver function: ALT or AST ≤ 2.5 times the normal high value (ULN)；Bilirubin ≤ 1.5 × ULN, serum APK ≤ 2.5 × ULN; Renal function：Serum creatinine ≤1.5×ULN, and creatinine clearance ≥60ml/min No organ transplant history 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 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: Patients undergoing chemotherapy or targeted therapy at the same time Long-term use of ACEI or ARB drugs for hypertension This radiotherapy site has been treated with radiotherapy；Combined with severe heart disease or major organ failure Have a history of drug abuse or alcohol addiction Combined active infection Combined with severe malnutrition or severe anemia Human immunodeficiency virus (HIV) infection During pregnancy or lactation 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； Researchers believe that it is not suitable for inclusion

Facility Information:

Facility Name

Jin Peng

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430071

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin Peng

Phone

13971235235

pjxp888@126.com

12. IPD Sharing Statement

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

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