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ISRCTN
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ISRCTN45836359
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DOI
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10.1186/ISRCTN45836359
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Intravesical Ialuril® plus oral combination of curcumine, quercetine, hyluronic acid (HA) and chondroitin sulphate (CS) for prophylaxis of recurrent non-muscle invasive transitional cell carcinoma (TCC) of the bladder
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Scientific title
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Intravesical Ialuril® plus oral combination of curcumine, quercetine, hyluronic acid (HA) and chondroitin sulphate (CS) for prophylaxis of recurrent non-muscle invasive transitional cell carcinoma (TCC) of the bladder: a prospective longitudinal investigative pilot non-randomised study
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Acronym
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N/A
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Serial number at source
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001/Ialuril_Oral
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Study hypothesis
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To test the hypothesis whether or not immediate post-TURBT intravesical instillation of a combination of HA and CS (Ialuril®) – repairing coating - followed by oral administration of a combination of HA and CS plus curcumine and quercetine – maintaining coating - is safe, tolerated and effective in preventing the recurrence of TCC after TURBT in patients with superficial low-intermediate risk pTa-1 TCC.
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Lay summary
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Lay summary under review 2
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Ethics approval
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Not provided at time of registration
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Study design
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Prospective longitudinal investigative pilot non-randomised (phase 1b) study
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Countries of recruitment
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Italy
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Disease/condition/study domain
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Superficial (non muscle invasive) transitional cell carcinoma
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Participants - inclusion criteria
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Patients (male and female) with single, ultrasound detected < 3 cm tumor diameter, or multiple 3 or less, each < 1 cm, low- and intermediate-grade (Grade II in old nomenclature) superficial TCC at the first diagnosis, confirmed by flexible cystoscopy and cold cup biopsy
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Participants - exclusion criteria
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1. Concomitant CIS
2. Involvement of the prostatic urethra
3. Neurogenic bladder
4. Diabetes mellitus type I and II
5. Previous bladder or prostate surgery (any kind)
6. Previous treatment with drugs (capsaicin, vanilloids, ovanil, botulinum toxin etc)
7. Further exclusion criteria were previous chemotherapies and/or pelvic radiotherapy
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Anticipated start date
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01/01/2012
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Anticipated end date
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31/12/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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20
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Interventions
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All the patients underwent standard transurethral resection of the visible lesions. Immediate post-TURBT intravesical instillation of a combination of HA and CS (Ialuril®: 50 ml/vial solution containing HA 800 mg and CS 1 mg) followed by oral treatment with pills (one a day for 90 days) containing CS 200 mg, HA 20 mg, quercitine 200 mg and curcumine 100 mg.
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Primary outcome measure(s)
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To investigate the safety, the tolerability and the efficacy of the combined treatment for the prevention of TCC recurrence.
Tolerability was reported as discontinuation or deviation of the protocol and safety as general or local side effects.
Efficacy was defined as the absence of recurrence as defined by negative ultrasound evaluation, negative urine cytology and negative endoscopic assessment after three month.
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Secondary outcome measure(s)
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Secondary end-point consists of morphological immunohistochemical assessment, comparing samples at entry and after three months for transient receptor protein vanilloids 1 (TRPV1) expression and GAGs as well
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Sources of funding
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Institut Biochimique SA (IBSA) (Italy)
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Trial website
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Publications
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Contact name
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Dr
Massimo
Lazzeri
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Address
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via Stamira d'Ancona 20
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City/town
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Milan
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Zip/Postcode
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20127
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Country
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Italy
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Sponsor
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Institut Biochimique SA (IBSA) (Italy)
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Address
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Via Emilia
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City/town
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Lodi
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Zip/Postcode
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26900
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Country
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Italy
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Sponsor website:
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http://www.ibsa-international.com/
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Date applied
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10/03/2013
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Last edited
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20/03/2013
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Date ISRCTN assigned
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20/03/2013
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