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

Plain English Summary

Lay summary under review 2

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 controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below 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

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.

Secondary outcome measures

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

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