Condition category
Cancer
Date applied
10/03/2013
Date assigned
20/03/2013
Last edited
19/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Massimo Lazzeri

ORCID ID

Contact details

via Stamira d'Ancona 20
Milan
20127
Italy

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 measures

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

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

http://www.ibsa-international.com/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

19/04/2017: Plain English summary added.