Pain Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | April 1, 2020 |
Est. primary completion date | January 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - Uncontrolled underlying diseases (ASA III or IV) - Post void residual urine = 100 ml - Bleeding tendency - Drug abuse - Chronic pelvic pain - Urinary tract infection - 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Cardarelli Hospital |
Dmochowski R. Antimuscarinic therapy in men with lower urinary tract symptoms: what is the evidence? Curr Urol Rep. 2006 Nov;7(6):462-7. Review. — View Citation
Fedurco M, Gregorová J, Šebrlová K, Kantorová J, Peš O, Baur R, Sigel E, Táborská 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. — View Citation
Sousa A, Piñeiro I, Rodríguez 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. — View Citation
Ustünes L, Laekeman GM, Gözler 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. — View Citation
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. — View Citation
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). pii: E2723. doi: 10.3390/molecules23102723. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | PPIUS | The PPIUS is a questionnaire developed to evaluate the patient perception of intensity of urgency | 1 and 6 weeks | |
Primary | PGI-1 | PGI-I is a validated tool to estimate the improvement or the deterioration associated to the treatment. | 1 and 6 weeks | |
Primary | 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 | |
Secondary | Qmax | Qmax (ml/s) is the maximum flow rate at uroflowmetry | 1 and 6 weeks | |
Secondary | Volume voided | Volume voided (ml) at uroflowmetry | 1 and 6 weeks | |
Secondary | RPM | Post-Void residual (ml) measures the amount of urine left in the bladder after urination. | 1 and 6 weeks |
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