Plain English Summary
Background and study aims
Transitional cell carcinoma (TCC) of the bladder is one of the most common cancers. In 75-85% of patients the cancer is contained inside the lining of the bladder (non-muscle-invasive bladder cancer). A surgical technique called complete transurethral resection of visible tumour (TURBT) is the gold standard treatment for non-invasive bladder tumours. A single dose of chemotherapy, usually mitomycin C, is delivered directly into the bladder using a catheter (intravesical therapy) to destroy any remaining microscopic tumour and prevent the cancer from coming back. Intravesical therapy is also used in a maintenance (long term) fashion to prolong the beneficial effects of the chemotherapy. Although immediate intravesical mitomycin C or epirubicin is highly recommended, it should not be used in patients with a bladder perforation as a small number of serious complications related to mitomycin C extravasation (leakage) have been reported. The bladder lining (urothelium) prevents undesirable substances penetrating the deeper layers of the bladder wall and neutralises toxic substances. Glycosaminoglycans (GAGs) make the inner bladder wall impervious to the contents of the urine. Two key components of the layer are hyaluronic acid (HA) and chondroitin sulphate (CS). The aim of this study is to find out whether intravesical HA and CS (Ialuril®) followed by oral HA and CS plus curcumine and quercetine are safe and effective at preventing the recurrence of TCC after TURBT.
Who can participate?
Patients aged over 18 with TCC
What does the study involve?
Patients receive intravesical HA and CS (Ialuril®) immediately after TURBT, followed by oral treatment with pills (one a day for 90 days) containing CS, HA, quercitine and curcumine. TCC recurrence is assessed using ultrasound, urine tests and endoscopic assessment after 3 months.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Institut Biochimique SA (IBSA) (Italy)
When is the study starting and how long is it expected to run for?
January 2012 to December 2013
Who is funding the study?
Institut Biochimique SA (IBSA) (Italy)
Who is the main contact?
Dr Massimo Lazzeri
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
001/Ialuril_Oral
Study information
Scientific title
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
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Prospective longitudinal investigative pilot non-randomised (phase 1b) study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Superficial (non muscle invasive) transitional cell carcinoma
Intervention
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.
Intervention type
Drug
Phase
Phase I
Drug names
Laluril®
Primary outcome measure
1. Tolerability, reported as discontinuation or deviation of the protocol and safety as general or local side effects
2. Efficacy, defined as the absence of recurrence as defined by negative ultrasound evaluation, negative urine cytology and negative endoscopic assessment after 3 months
Secondary outcome measures
Morphological immunohistochemical assessment, comparing samples at entry and after 3 months for transient receptor protein vanilloids 1 (TRPV1) expression and GAGs
Overall trial start date
01/01/2012
Overall trial end date
31/12/2013
Reason abandoned (if study stopped)
Local ethical committees requested several changes
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
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
Recruitment start date
01/01/2012
Recruitment end date
31/12/2013
Locations
Countries of recruitment
Italy
Trial participating centre
via Stamira d'Ancona 20
Milan
20127
Italy
Sponsor information
Organisation
Institut Biochimique SA (IBSA) (Italy)
Sponsor details
Via Emilia
Lodi
26900
Italy
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Institut Biochimique SA (IBSA) (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list