Bladder CancerNCT04148677
Protoves M1® Syrup in Controlling Adverse Event During HIVEC® Instillations
An observational study of Bladder Cancer and LUTS, run by Cardarelli Hospital.
Trial summary
100 patients with bladder cancer whose underwent Hyperthermic Intravesical Chemotherapy (HIVEC®) will be randomized in two groups (Group A: PROTOVES M1 SYRUP, Group B: NO TREATMENT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, LUTS, Pain
- What is being tested?
- Protoves M1®
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Apr 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who referred to a general hospital to receive endoscopic treatment for bladder cancer (TURB) and then the endovescical chemioprofilaxis.
Who may be able to join
- Intermediate-and high-risk NMIBC (non-muscle invasive bladder cancer) patients.
- Therapeutic program of HIVEC® (Recirculant hyperthermic IntraVEsical chemotherapy).
- Must be able to drink a syrup.
Who cannot join
- Uncontrolled underlying diseases (ASA III or IV)
- Post void residual urine ≥ 100 ml
- Bleeding tendency
- Drug abuse
- Chronic pelvic pain
- Urinary tract infection
Show all 12Show fewer
- Neurological disease
- Bladder lithiasis
- Renal or liver failure
- Tachycardia and heart failure.
- Male patients with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH)with abnormal values of uroflowmetry
- Male patients with lower urinary tract symptoms (LUTS) that assume medical treatment for BPH.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Role of Protopine Associated With Nuciferine (Protoves M1® Syrup) in Controlling Adverse Event During HIVEC® Instillations
100 patients with bladder cancer whose underwent Hyperthermic Intravesical Chemotherapy (HIVEC®) will be randomized in two groups (Group A: PROTOVES M1 SYRUP, Group B: NO TREATMENT). The aim of this study will be to analyse the role of two alkaloid, Protopine and Nuciferine (Protoves-M1 ®) in the prevention and the treatment of the low and mild grade adverse events related to the use of HIVEC® instillations.
Read the detailed description
100 patients with bladder cancer whose underwent Hyperthermic Intravesical Chemotherapy (HIVEC®) will be randomized in two groups (Group A: PROTOVES M1 SYRUP, Group B: NO TREATMENT). The aim of this study will be to analyse the role of two alkaloid, Protopine and Nuciferine (Protoves-M1 ®) in the prevention and the treatment of the low and mild grade adverse events related to the use of HIVEC® instillations.
At the baseline data on demographic and anthropometric features (age, weight, height, BMI), lifestyle characteristics (smoke, alcohol), any comorbidities (hypertension, diabetes mellitus, etc.) will be collected. All patients will be undergone to a clinical evaluation (comprised general, genital and urologic examination). Before starting the treatment, the following measurements will be collected: prostate volume by transrectal ultrasound, PSA, uroflowmetry (Qmax, Volume Voided, Post-Void Residual), IPSS (International Prostatic Symptoms Score) questionnaire, OverActive Bladder questionnaire-short form (OABq-SF) 6 and 13, patient perception of intensity of urgency scale (PPIUS), and visual analogue scale (VAS). PSA and IPSS will be investigated only in male pts. In addition, the patient impression of improvement will be assessed. Improvement will be evaluated with the Patient Global Impression of Improvement questionnaire (PGI-I), a validated tool to estimate the improvement or the deterioration associated to the treatment.
The primary endpoint was the evaluation of the efficacy of the therapy with Protoves-M1 in controlling of the irritative symptoms, including nocturia, urinary frequency, bladder pain, urgency and urge incontinence related to the chemo-hyperthermia treatment. The secondary endpoint evaluated was the influences of the treatment on the uroflowmetric parameters.
After 1 and 6 weeks of therapy all patients will be undergone to a clinical and instrumental evaluation : Uroflow-Qmax (ml/s), Uroflow-Volume voided (ml),Uroflow-RPM (ml), IPSS total, OAB-q SF 6, OAB-q SF 13, PPIUS, PGI-I, VAS scale will be collected.
- Conditions
- Bladder Cancer, LUTS, Pain
- Being tested
- Protoves M1®
- Medical subject headings
- Urinary Bladder Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protoves M1®Dietary supplement
A combination of two alkaloid, Protopine and Nuciferine (Protoves-M1 ®)
| Study group | Role | What they receive |
|---|---|---|
| Protoves M1® syrup | A combination of two alkaloid, Protopine and Nuciferine Receives: Dietary Supplement: Protoves M1® | |
| No treatment | Patients will not receive a treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPSS total
The International Prostate Symptom Score (I-PSS) is based on the answers to some questions concerning urinary symptoms and one question concerning quality of life.
Measured: 1 and 6 weeks
OAB-q SF 6
The OAB-q SF 6 is a questionnaire developed to evaluate the overactive bladder symptom and health-related quality of life.
Measured: 1 and 6 weeks
OAB-q SF 13
The OAB-q SF 6 is a questionnaire developed to evaluate the overactive bladder symptom and health-related quality of life.
Measured: 1 and 6 weeks
PPIUS
The PPIUS is a questionnaire developed to evaluate the patient perception of intensity of urgency
Measured: 1 and 6 weeks
PGI-1
PGI-I is a validated tool to estimate the improvement or the deterioration associated to the treatment.
Measured: 1 and 6 weeks
VAS scale
Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions.
Measured: 1 and 6 weeks
Secondary outcomes (3)
Qmax
Qmax (ml/s) is the maximum flow rate at uroflowmetry
Measured: 1 and 6 weeks
Volume voided
Volume voided (ml) at uroflowmetry
Measured: 1 and 6 weeks
RPM
Post-Void residual (ml) measures the amount of urine left in the bladder after urination.
Measured: 1 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardarelli Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Chiancone, Cardarelli Hospital
- Investigators
- Francesco Chiancone, Principal investigator, AORN A.Cardarelli Urology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148677
- Sponsor's protocol ID
- M1-2019
- Status last verified
- Oct 2019
- First submitted
- 25 Oct 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sousa A, Pineiro I, Rodriguez S, Aparici V, Monserrat V, Neira P, Carro E, Murias C, Uribarri C. Recirculant hyperthermic IntraVEsical chemotherapy (HIVEC) in intermediate-high-risk non-muscle-invasive bladder cancer. Int J Hyperthermia. 2016 Jun;32(4):374-80. doi: 10.3109/02656736.2016.1142618. Epub 2016 Feb 25.
PubMed 26915466Ustunes L, Laekeman GM, Gozler B, Vlietinck AJ, Ozer A, Herman AG. In vitro study of the anticholinergic and antihistaminic activities of protopine and some derivatives. J Nat Prod. 1988 Sep-Oct;51(5):1021-2. doi: 10.1021/np50059a043. No abstract available.
PubMed 2904975Fedurco M, Gregorova J, Sebrlova K, Kantorova J, Pes O, Baur R, Sigel E, Taborska E. Modulatory Effects of Eschscholzia californica Alkaloids on Recombinant GABAA Receptors. Biochem Res Int. 2015;2015:617620. doi: 10.1155/2015/617620. Epub 2015 Oct 5.
PubMed 26509084Zhang C, Deng J, Liu D, Tuo X, Yu Y, Yang H, Wang N. Nuciferine Inhibits Proinflammatory Cytokines via the PPARs in LPS-Induced RAW264.7 Cells. Molecules. 2018 Oct 22;23(10):2723. doi: 10.3390/molecules23102723.
PubMed 30360404Wang MX, Zhao XJ, Chen TY, Liu YL, Jiao RQ, Zhang JH, Ma CH, Liu JH, Pan Y, Kong LD. Nuciferine Alleviates Renal Injury by Inhibiting Inflammatory Responses in Fructose-Fed Rats. J Agric Food Chem. 2016 Oct 26;64(42):7899-7910. doi: 10.1021/acs.jafc.6b03031. Epub 2016 Oct 18.
PubMed 27718563Dmochowski R. Antimuscarinic therapy in men with lower urinary tract symptoms: what is the evidence? Curr Urol Rep. 2006 Nov;7(6):462-7. doi: 10.1007/s11934-006-0055-4.
PubMed 17052442
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Protopine Associated With Nuciferine (Protoves M1® Syrup) in Controlling Adverse Event During HIVEC® Instillations
- ClinicalTrials.gov ID
- NCT04148677
- Acronym / sponsor ID
- M1-2019
- Conditions
- Bladder Cancer, LUTS, Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cardarelli HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 1 Nov 2019 (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.
100 patients with bladder cancer whose underwent Hyperthermic Intravesical Chemotherapy (HIVEC®) will be randomized in two groups (Group A: PROTOVES M1 SYRUP, Group B: NO TREATMENT). The aim of this study will be to analyse the role of two alkaloid, Protopine and Nuciferine (Protoves-M1 ®) in the prevention and the treatment of the low and mild grade adverse events related to the use of HIVEC® instillations.
Detailed description
100 patients with bladder cancer whose underwent Hyperthermic Intravesical Chemotherapy (HIVEC®) will be randomized in two groups (Group A: PROTOVES M1 SYRUP, Group B: NO TREATMENT). The aim of this study will be to analyse the role of two alkaloid, Protopine and Nuciferine (Protoves-M1 ®) in the prevention and the treatment of the low and mild grade adverse events related to the use of HIVEC® instillations.
At the baseline data on demographic and anthropometric features (age, weight, height, BMI), lifestyle characteristics (smoke, alcohol), any comorbidities (hypertension, diabetes mellitus, etc.) will be collected. All patients will be undergone to a clinical evaluation (comprised general, genital and urologic examination). Before starting the treatment, the following measurements will be collected: prostate volume by transrectal ultrasound, PSA, uroflowmetry (Qmax, Volume Voided, Post-Void Residual), IPSS (International Prostatic Symptoms Score) questionnaire, OverActive Bladder questionnaire-short form (OABq-SF) 6 and 13, patient perception of intensity of urgency scale (PPIUS), and visual analogue scale (VAS). PSA and IPSS will be investigated only in male pts. In addition, the patient impression of improvement will be assessed. Improvement will be evaluated with the Patient Global Impression of Improvement questionnaire (PGI-I), a validated tool to estimate the improvement or the deterioration associated to the treatment.
The primary endpoint was the evaluation of the efficacy of the therapy with Protoves-M1 in controlling of the irritative symptoms, including nocturia, urinary frequency, bladder pain, urgency and urge incontinence related to the chemo-hyperthermia treatment. The secondary endpoint evaluated was the influences of the treatment on the uroflowmetric parameters.
After 1 and 6 weeks of therapy all patients will be undergone to a clinical and instrumental evaluation : Uroflow-Qmax (ml/s), Uroflow-Volume voided (ml),Uroflow-RPM (ml), IPSS total, OAB-q SF 6, OAB-q SF 13, PPIUS, PGI-I, VAS scale will be collected.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protoves M1® syrup | – | Dietary Supplement: Protoves M1®A combination of two alkaloid, Protopine and Nuciferine |
| No treatment | – | –Patients will not receive a treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who referred to a general hospital to receive endoscopic treatment for bladder cancer (TURB) and then the endovescical chemioprofilaxis.
Key inclusion criteria (3 listed)
- Intermediate-and high-risk NMIBC (non-muscle invasive bladder cancer) patients.
- Therapeutic program of HIVEC® (Recirculant hyperthermic IntraVEsical chemotherapy).
- Must be able to drink a syrup.
Key exclusion criteria (12 listed)
- Uncontrolled underlying diseases (ASA III or IV)
- Post void residual urine ≥ 100 ml
- Bleeding tendency
- Drug abuse
- Chronic pelvic pain
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 |
|---|---|---|
| Protoves M1®A combination of two alkaloid, Protopine and Nuciferine (Protoves-M1 ®) | Dietary supplement | Protoves M1® syrup |
Primary outcome
IPSS total
Time frame: 1 and 6 weeks
The International Prostate Symptom Score (I-PSS) is based on the answers to some questions concerning urinary symptoms and one question concerning quality of life.
OAB-q SF 6
Time frame: 1 and 6 weeks
The OAB-q SF 6 is a questionnaire developed to evaluate the overactive bladder symptom and health-related quality of life.
OAB-q SF 13
Time frame: 1 and 6 weeks
The OAB-q SF 6 is a questionnaire developed to evaluate the overactive bladder symptom and health-related quality of life.
PPIUS
Time frame: 1 and 6 weeks
The PPIUS is a questionnaire developed to evaluate the patient perception of intensity of urgency
PGI-1
Time frame: 1 and 6 weeks
PGI-I is a validated tool to estimate the improvement or the deterioration associated to the treatment.
VAS scale
Time frame: 1 and 6 weeks
Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions.
3 secondary outcomes
Qmax
Time frame: 1 and 6 weeks
Volume voided
Time frame: 1 and 6 weeks
RPM
Time frame: 1 and 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Background: PubMed 26915466Sousa A, Pineiro I, Rodriguez S, Aparici V, Monserrat V, Neira P, Carro E, Murias C, Uribarri C. Recirculant hyperthermic IntraVEsical chemotherapy (HIVEC) in intermediate-high-risk non-muscle-invasive bladder cancer. Int J Hyperthermia. 2016 Jun;32(4):374-80. doi: 10.3109/02656736.2016.1142618. Epub 2016 Feb 25.
- Background: PubMed 2904975Ustunes L, Laekeman GM, Gozler B, Vlietinck AJ, Ozer A, Herman AG. In vitro study of the anticholinergic and antihistaminic activities of protopine and some derivatives. J Nat Prod. 1988 Sep-Oct;51(5):1021-2. doi: 10.1021/np50059a043. No abstract available.
- Background: PubMed 26509084Fedurco M, Gregorova J, Sebrlova K, Kantorova J, Pes O, Baur R, Sigel E, Taborska E. Modulatory Effects of Eschscholzia californica Alkaloids on Recombinant GABAA Receptors. Biochem Res Int. 2015;2015:617620. doi: 10.1155/2015/617620. Epub 2015 Oct 5.
- Background: PubMed 30360404Zhang C, Deng J, Liu D, Tuo X, Yu Y, Yang H, Wang N. Nuciferine Inhibits Proinflammatory Cytokines via the PPARs in LPS-Induced RAW264.7 Cells. Molecules. 2018 Oct 22;23(10):2723. doi: 10.3390/molecules23102723.
- Background: PubMed 27718563Wang MX, Zhao XJ, Chen TY, Liu YL, Jiao RQ, Zhang JH, Ma CH, Liu JH, Pan Y, Kong LD. Nuciferine Alleviates Renal Injury by Inhibiting Inflammatory Responses in Fructose-Fed Rats. J Agric Food Chem. 2016 Oct 26;64(42):7899-7910. doi: 10.1021/acs.jafc.6b03031. Epub 2016 Oct 18.
- Background: PubMed 17052442Dmochowski R. Antimuscarinic therapy in men with lower urinary tract symptoms: what is the evidence? Curr Urol Rep. 2006 Nov;7(6):462-7. doi: 10.1007/s11934-006-0055-4.
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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.
Francesco Chiancone principal investigator
AORN A.Cardarelli Urology Department
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and LUTS, run by Cardarelli Hospital.
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 3 inclusion and 12 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 1 Nov 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Francesco Chiancone (00393408639711, francescok86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPSS total (time frame: 1 and 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04148677, which also lists 6 linked publications.
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 1 Nov 2019.