Bladder CancerPhase 2NCT04493489
Propranolol Adjuvant Treatment of Bladder Cancer
A Phase 2 study testing Propranolol Hydrochloride and BCG in people with Bladder Cancer, run by Central South University.
Trial summary
Bladder cancer (bladder cancer) is the tenth most common cancer in the world, ranking 13th in the number of deaths. There are about 549000 new cases of bladder cancer worldwide, with 200000 deaths and a higher incidence rate in men than in women. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Propranolol Hydrochloride and BCG
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- No sites listed yet
- Study dates
- 6 Sep 2020to 6 Sep 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 to 75
- Patients with pathologically confirmed non-muscle invasive bladder cancer (T1 / Ta high grade / CIS), according to the 2004 WHO classification criteria
- No evidence of patients with muscular invasive disease
- American Oncology Group ECOG score <2
- Patients' expected survival time should be more than 3 months
- Organ function and hematopoietic function must meet the following requirements: hemoglobin (HGB) ≥ 90g / L; white blood cell count (WBC) ≥ 3 × 10 ^ 9 / L; absolute neutrophil count (ANC) ≥ 1.5 × 10 ^ 9 / L Platelet count (PLT) ≥100 × 10 ^ 9 / L; total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase ( ALT) ≤ 2.5 × ULN; if abnormal liver function is due to tumor liver metastasis, AST or ALT ≤ 5 × ULN; serum creatinine (Cr) ≤ 1.5 × ULN; international standardized ratio (INR) or plasma prothrombin time PT) ≤1.5 × ULN
- Blood pressure with acceptable surgery: blood pressure greater than 90 / 60mmHg, resting heart rate greater than 60 beats / min
- Volunteer to participate in clinical research; fully understand, inform, and sign the consent form; willing to follow and have the ability to complete all test procedures
Who cannot join
- Contraindications for propranolol: bronchial asthma, cardiogenic shock, cardiac block (II-III degree Atrioventricular conduction block), severe or acute heart failure, sinus bradycardia
- In use or have used any beta-blockers for disease reasons in the past two years
- Patients with other malignancies within 5 years before enrollment, in addition to cervical carcinoma in situ and cured skin basal cell carcinoma with appropriate treatment
- Immunodeficiency, such as patients with HIV infection or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation
- Patients with tumor brain metastases and bone marrow metastases were excluded, and patients with liver metastases and lung metastases could be included
- Participants who have participated in clinical studies of drugs other than BCG within 4 weeks
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- Patients with a history of allergy to propranolol
- Alcohol, drug or substance abuse history in the past year
- Subject has an active infection or an unexplained fever during screening, before the first dose> 38.5 degrees(According to the researcher's judgment, the subjects can be enrolled due to the fever caused by the tumor)
- Any situation that the investigator believes may increase the risk of the subject or interfere with clinical trials
About this study
Official title: Propranolol Adjuvant Treatment of Bladder Cancer: a Randomized Phase II Clinical Trial
Bladder cancer (bladder cancer) is the tenth most common cancer in the world, ranking 13th in the number of deaths. There are about 549000 new cases of bladder cancer worldwide, with 200000 deaths and a higher incidence rate in men than in women. In 2013, the incidence rate of bladder cancer was high in China, accounting for 2.02% of all new cases. Bladder cancer has become a major disease threatening people's life and health. Therefore, the exploration of the mechanism of the occurrence and development of bladder cancer and effective drugs has been an important focus of bladder cancer research. The current treatment of bladder cancer is mainly TURBT (transurethral resection of bladder tumour) resection and BCG, chemotherapy adjuvant treatment, but its recurrence and metastasis still exist, so this study aims to explore an effective drug treatment. The purpose of this study was to investigate the safety and efficacy of propranolol in adjuvant BCG therapy, and whether propranolol can effectively alleviate the metastasis and recurrence of bladder cancer and improve the survival time after bladder cancer surgery.
- Conditions
- Bladder Cancer
- Being tested
- Propranolol Hydrochloride, BCG
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol HydrochlorideDrug
Trial group: BCG + propranolol: after TURBT administered for 2 consecutive years, oral propranolol, starting dose 10mg, tid, then 20mg, tid,lastly increased to 40mg, bid. After the last BCG infusion, propranolol was gradually reduced, in the order of 20 mg, tid to 10 mg, tid.
BCGDrug
Control group: BCG vaccine: After TURBT, the first year: once a week for 6 times, from the 7th week, once every 2 weeks, and 3 times. Administer once a month starting from the 13th week and continue to give 10 times. Second and third years: once a month, 12 times a year.
| Study group | Role | What they receive |
|---|---|---|
| BCG | Placebo comparator | After TURBT, the first year: once a week for 6 times, from the 7th week, once every 2 weeks, and 3 times. Administer once a month starting from the 13th week and continue to give 10 times. Second and third years: once a month, 12 times a year. Receives: Drug: BCG |
| Propranolol plus BCG | Experimental | After TURBT administered for 2 consecutive years, oral propranolol, starting dose 10mg, tid, then 20mg, tid,lastly increased to 40mg, bid. After the last BCG infusion, propranolol was gradually reduced, in the order of 20 mg, tid to 10 mg, tid. Receives: Drug: Propranolol Hydrochloride; Drug: BCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
two-year recurrence-free survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start6 Sep 2020 (estimated)
- Primary completion6 Sep 2023 (estimated)
- Study completion6 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yijing He, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493489
- Sponsor's protocol ID
- 2020/prop/bladder/CSU
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2020
- Last updated
- 30 Jul 2020
- 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 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propranolol Adjuvant Treatment of Bladder Cancer: a Randomized Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT04493489
- Acronym / sponsor ID
- 2020/prop/bladder/CSU
- Conditions
- Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 6 Sep 2020 (estimated)
- Primary completion
- 6 Sep 2023 (estimated)
- Study completion
- 6 Sep 2024 (estimated)
- First posted
- 30 Jul 2020 (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.
Bladder cancer (bladder cancer) is the tenth most common cancer in the world, ranking 13th in the number of deaths. There are about 549000 new cases of bladder cancer worldwide, with 200000 deaths and a higher incidence rate in men than in women. In 2013, the incidence rate of bladder cancer was high in China, accounting for 2.02% of all new cases. Bladder cancer has become a major disease threatening people's life and health. Therefore, the exploration of the mechanism of the occurrence and development of bladder cancer and effective drugs has been an important focus of bladder cancer research. The current treatment of bladder cancer is mainly TURBT (transurethral resection of bladder tumour) resection and BCG, chemotherapy adjuvant treatment, but its recurrence and metastasis still exist, so this study aims to explore an effective drug treatment. The purpose of this study was to investigate the safety and efficacy of propranolol in adjuvant BCG therapy, and whether propranolol can effectively alleviate the metastasis and recurrence of bladder cancer and improve the survival time after bladder cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCG | Placebo comparator | Drug: BCGAfter TURBT, the first year: once a week for 6 times, from the 7th week, once every 2 weeks, and 3 times. Administer once a month starting from the 13th week and continue to give 10 times. Second and third years: once a month, 12 times a year. |
| Propranolol plus BCG | Experimental | Drug: Propranolol Hydrochloride, Drug: BCGAfter TURBT administered for 2 consecutive years, oral propranolol, starting dose 10mg, tid, then 20mg, tid,lastly increased to 40mg, bid. After the last BCG infusion, propranolol was gradually reduced, in the order of 20 mg, tid to 10 mg, tid. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ages 18 to 75
- Patients with pathologically confirmed non-muscle invasive bladder cancer (T1 / Ta high grade / CIS), according to the 2004 WHO classification criteria
- No evidence of patients with muscular invasive disease
- American Oncology Group ECOG score <2
- Patients' expected survival time should be more than 3 months
Key exclusion criteria (10 listed)
- Contraindications for propranolol: bronchial asthma, cardiogenic shock, cardiac block (II-III degree Atrioventricular conduction block), severe or acute heart failure, sinus bradycardia
- In use or have used any beta-blockers for disease reasons in the past two years
- Patients with other malignancies within 5 years before enrollment, in addition to cervical carcinoma in situ and cured skin basal cell carcinoma with appropriate treatment
- Immunodeficiency, such as patients with HIV infection or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation
- Patients with tumor brain metastases and bone marrow metastases were excluded, and patients with liver metastases and lung metastases could be included
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 |
|---|---|---|
| Propranolol HydrochlorideTrial group: BCG + propranolol: after TURBT administered for 2 consecutive years, oral propranolol, starting dose 10mg, tid, then 20mg, tid,lastly increased to 40mg, bid. After the last BCG infusion, propranolol was gradually reduced, in the order of 20 mg, tid to 10 mg, tid. | Drug | Propranolol plus BCG |
| BCGControl group: BCG vaccine: After TURBT, the first year: once a week for 6 times, from the 7th week, once every 2 weeks, and 3 times. Administer once a month starting from the 13th week and continue to give 10 times. Second and third years: once a month, 12 times a year. | Drug | BCG, Propranolol plus BCG |
Primary outcome
two-year recurrence-free survival
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol Hydrochloride and BCG in people with Bladder Cancer, run by Central South University.
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 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
two-year recurrence-free survival (time frame: 24 months). 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 30 Jul 2020.