Protoves M1® Syrup in Controlling Adverse Event During HIVEC® Instillations
NCT04148677 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2019-11-01
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
Interventions
- DIETARY_SUPPLEMENT
-
Protoves M1®
A combination of two alkaloid, Protopine and Nuciferine (Protoves-M1 ®)
Sponsors & Collaborators
-
Cardarelli Hospital
lead OTHER
Principal Investigators
-
Francesco Chiancone · AORN A.Cardarelli Urology Department
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-12-01
- Primary Completion
- 2020-01-01
- Completion
- 2020-04-01
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