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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Study Group for Urogenital Diseases, Italy
- Enrollment
- 100
- Locations
- 7
- Primary Endpoint
- Rate of patients
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Rate of patients
Time Frame: 12 months
The rate of patients who stopped treatment with intravesical or oral Ialuril due to intollerance or adverse events
Secondary Outcomes
- comparative analysis of score of QOL(12 months)
- comparative analysis of score between the two groups through EPIC(12 months)
- comparative analysis of score between the two groups through ICIQ(12 months)
- comparative analysis of score between the two groups through IPSS(12 months)