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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protoves M1® syrup | A combination of two alkaloid, Protopine and Nuciferine |
| |
| No treatment | Patients will not receive a treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protoves M1® | Dietary Supplement | A combination of two alkaloid, Protopine and Nuciferine (Protoves-M1 ®) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 1 and 6 weeks |
| PPIUS | The PPIUS is a questionnaire developed to evaluate the patient perception of intensity of urgency | 1 and 6 weeks |
| PGI-1 | PGI-I is a validated tool to estimate the improvement or the deterioration associated to the treatment. | 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. | 1 and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Qmax | Qmax (ml/s) is the maximum flow rate at uroflowmetry | 1 and 6 weeks |
| Volume voided | Volume voided (ml) at uroflowmetry | 1 and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who referred to a general hospital to receive endoscopic treatment for bladder cancer (TURB) and then the endovescical chemioprofilaxis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Chiancone | Contact | 00393408639711 | francescok86@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Chiancone | AORN A.Cardarelli Urology Department | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26915466 | Background | 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. | |
| 2904975 | Background |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| RPM | Post-Void residual (ml) measures the amount of urine left in the bladder after urination. | 1 and 6 weeks |
| Ustunes 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. |
| 26509084 | Background | Fedurco 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. |
| 30360404 | Background | Zhang 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. |
| 27718563 | Background | Wang 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. |
| 17052442 | Background | Dmochowski 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |