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

Cardarelli Hospital

Status: Unknown

Conditions: LUTS; Bladder Cancer; Pain

Treatments: Dietary Supplement: Protoves M1®

Study type: Observational

Funder types: Other

Identifiers

NCT04148677

M1-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Protoves M1® syrup

Description:

A combination of two alkaloid, Protopine and Nuciferine

Treatment:

Dietary Supplement: Protoves M1®

No treatment

Description:

Patients will not receive a treatment