Protoves M1® Syrup in Controlling Adverse Event During HIVEC® Instillations

NCT04148677 | Unknown

• 1 other identifier: M1-2019
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Bladder Cancer; LUTS; Pain

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (3)

• Qmax

  1 and 6 weeks

• Volume voided

  1 and 6 weeks

• RPM

  1 and 6 weeks

Study Arms (2)

Protoves M1® syrup

A combination of two alkaloid, Protopine and Nuciferine

Dietary Supplement: Protoves M1®

No treatment

Patients will not receive a treatment

Interventions

Protoves M1® DIETARY_SUPPLEMENT

A combination of two alkaloid, Protopine and Nuciferine (Protoves-M1 ®)

Protoves M1® syrup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who referred to a general hospital to receive endoscopic treatment for bladder cancer (TURB) and then the endovescical chemioprofilaxis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardarelli Hospital: lead

Related Publications (6)

• 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.

  PMID: 26915466 BACKGROUND

• 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.

  PMID: 2904975 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.

  PMID: 26509084 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.

  PMID: 30360404 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.

  PMID: 27718563 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.

  PMID: 17052442 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Pain

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francesco Chiancone

  AORN A.Cardarelli Urology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Chiancone

CONTACT

00393408639711; francescok86@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Medical Director, Principal Investigator

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 1, 2019
• Study Start: December 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: April 1, 2020
• Last Updated: November 1, 2019

Record last verified: 2019-10