The Role and Intervention of TGF-β in Abdominal Radiation... | NCT03613506

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

NCT03613506

Sponsor

Wuhan University

Status

Unknown status

Last Update Posted

Feb 14, 2022Actual

Enrollment

226Estimated

Phase

Phase 2

Conditions

Radiotherapy Side Effect
Taking Captopril

Interventions

Captopril 12.5 Mg

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 25, 2019Actual

Primary Completion Date

Jun 25, 2022Estimated

Completion Date

Dec 25, 2022Estimated

First Submitted Date

Jul 23, 2018

First Submission Date that Met QC Criteria

Aug 1, 2018

First Posted Date

Aug 3, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2022

Last Update Posted Date

Feb 14, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

226Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Peripheral blood TGF-β content before and after radiotherapy	Experimental		Drug: Captopril 12.5 Mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Captopril 12.5 Mg	Drug	Taking captopril 12.5mg b.i.d for two months before radiotherapy.	Peripheral blood TGF-β content before and after radiotherapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D011392	Proline
D007098	Imino Acids
D000598	Amino Acids, Cyclic
D000596	Amino Acids