Trial | NCT03493997  Report issue

Title

Multicentre International STudy for the Prevention With Ialuril® of Radio-induced Cystitis (MISTIC)
An Investigative, Randomized, Open, Pilot Study to Assess the Tolerability, Safety and Efficacy of HAcid/CS Intravesical Instillations Plus an Oral Combination of Curcumin,Quercetin, HA and CS in Prevention of Radiation Induced Cystitis

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    100
The study is randomized and it will be conducted in the field of routine clinical practice. A total of 100 consecutive patients planned to receive radiotherapy for prostate cancer will be enrolled.

The patients will enter the study as controls (50 patients that won't receive any experimental IMP) or as treated-group (50 patients that will be also treated with the experimental IMPs, Ialuril® and Ialuril® Soft Gels) according to a predefined, centre-specific randomization.
Radiotherapy will last for 6 weeks. During planning of treatment, regimen and average dose to the whole bladder will be recorded to assess the impact of EBRT on urinary symptoms.

The treated-group will receive also intravesical Ialuril® weekly for 6 weeks (in the 24 hours before every radiation therapy weekly schedule), plus oral treatment with Ialuril® Soft Gels capsules (1 capsule twice a day after meals, at a distance of 12 hours, for 12 weeks).

The control-group will receive radiotherapy only for 6 weeks.

The Primary Objective is to assess the tolerability and safety of HA-CS intravesical instillations (Ialuril®) plus an oral combination of curcumin, quercetin, HA and CS (Ialuril® Soft Gels) in male patients undergoing radiotherapy for prostate cancer The efficacy of the treatment will be evaluated at the end of the study once received all the crfs.
Study Started
Apr 04
2017
Primary Completion
Oct 31
2018
Study Completion
May 31
2020
Last Update
Jul 23
2020

Combination Product Radiotherapy+IAluril®+Ialuril Soft Gels®

Radiotherapy+IAluril®+Ialuril Soft Gels®

Radiation Radiotherapy only

Radiotherapy only

Radiotherapy+Ialuril®+Ialuril Soft Gels® Experimental

Radiotherapy+Ialuril®+Ialuril Soft Gels®

Radiotherapy only Active Comparator

Radiotherapy only

Criteria 

Inclusion Criteria:

Male patients planned to receive primary radiotherapy for prostate cancer.

Exclusion Criteria:

Female patients
Patients with a life expectancy of less than 24 months
with radiological confirmed metastasis
with documented urethral strictures
undergoing chemotherapy
who received brachytherapy
who received chemo-radiotherapy for prostate cancer in the past
previously treated with Bacillus Calmette-Guerin (BCG)
with post-void residual (PVR) > 200ml
with clinical evidence of bladder calculi
with neurogenic bladder or neurologic disease at risk for neurogenic bladder
suffering from any lower urinary infections (UTIs, tuberculosis)
with unstable cardiovascular disease
with Congestive Heart Failure (CHF)
with current nitrate use
with current anticoagulants use (i.e. warfarin, heparin, etc.)
with clinically significant hepatobiliary or renal disease
with history of significant CNS injuries within 6 months
with any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
No Results Posted