Radiotherapy Side EffectPhase 2NCT03613506
The Role and Intervention of TGF-β in Abdominal Radiation Injury
A Phase 2 study testing Captopril 12.5 Mg in people with Radiotherapy Side Effect and Taking Captopril, run by Wuhan University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Radiotherapy Side Effect, Taking Captopril
- What is being tested?
- Captopril 12.5 Mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2019to 25 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jin Peng
Wuhan, Hubei, 430071
Jin Peng, 13971235235, pjxp888@126.com
About this study
Official title: 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.
- Conditions
- Radiotherapy Side Effect, Taking Captopril
- Being tested
- Captopril 12.5 Mg
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Captopril 12.5 MgDrug
Taking captopril 12.5mg b.i.d for two months before radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral blood TGF-β content before and after radiotherapy | Experimental | Not described Receives: Drug: Captopril 12.5 Mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start25 Oct 2019
- Primary completion25 Jun 2022 (estimated)
- Study completion25 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy Side EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Fuxiang, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613506
- Sponsor's protocol ID
- HBCCS AB-01
- Status last verified
- Jan 2022
- First submitted
- 23 Jul 2018
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of TGF-β in Abdominal Radiation Injury and Taking Medicine to Block TGF-β for Protecting Normal Organization
- ClinicalTrials.gov ID
- NCT03613506
- Acronym / sponsor ID
- HBCCS AB-01
- Conditions
- Radiotherapy Side Effect, Taking Captopril
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 25 Jun 2022 (estimated)
- Study completion
- 25 Dec 2022 (estimated)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral blood TGF-β content before and after radiotherapy | Experimental | Drug: Captopril 12.5 Mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Captopril 12.5 MgTaking captopril 12.5mg b.i.d for two months before radiotherapy. | Drug | Peripheral blood TGF-β content before and after radiotherapy |
Primary outcome
Study the effect of abdominal radiation therapy on peripheral blood TGFβ levels
Time frame: 12 weeks
The levels of TGF-β in peripheral blood of patients before and after radiotherapy were compared.
Blocking TGFβ for protective effect on normal tissues
Time frame: 12 weeks
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Captopril 12.5 Mg in people with Radiotherapy Side Effect and Taking Captopril, run by Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the effect of abdominal radiation therapy on peripheral blood TGFβ levels (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.