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Trial record 56 of 80 for:    "curcumin" and "cancer"

Multicentre International STudy for the Prevention With Ialuril® of Radio-induced Cystitis (MISTIC) (MISTIC)

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ClinicalTrials.gov Identifier: NCT03493997
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Study Group for Urogenital Diseases, Italy

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Combination Product: Radiotherapy+IAluril®+Ialuril Soft Gels® Radiation: Radiotherapy only Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Radiotherapy+Ialuril®+Ialuril Soft Gels®
Radiotherapy+Ialuril®+Ialuril Soft Gels®
Combination Product: Radiotherapy+IAluril®+Ialuril Soft Gels®
Radiotherapy+IAluril®+Ialuril Soft Gels®

Active Comparator: Radiotherapy only
Radiotherapy only
Radiation: Radiotherapy only
Radiotherapy only




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. comparative analysis of score between the two groups through ICIQ [ Time Frame: 12 months ]

    comparative analysis of score between the two groups (active arm vs. no drug arm)following questionnaires scores.

    Questionnaires:

    • ICIQ-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) questionnaire and bladder diary - Scale: Never - Occasionally

    • Sometimes - Most of the time - All of the time

  2. comparative analysis of score between the two groups through EPIC [ Time Frame: 12 months ]

    comparative analysis of score between the two groups (active arm vs. no drug arm)following questionnaires scores.

    Expanded Prostate Cancer Index Composite (EPIC) - Urinary Domain Scale :From 1 to 5 ( 1 smallest, 5 highest)


  3. comparative analysis of score of QOL [ Time Frame: 12 months ]

    comparative analysis of score between the two groups (active arm vs. no drug arm)following questionnaires scores.

    EQ-5D-5L (QoL) -

    Scale:

    I am not anxious or depressed I am slightly anxious or depressed I am moderately anxious or depressed I am severely anxious or depressed I am extremely anxious or depressed


  4. comparative analysis of score between the two groups through IPSS [ Time Frame: 12 months ]

    comparative analysis of score between the two groups (active arm vs. no drug arm)following questionnaires scores.

    IPSS Scale: 0 to 5 (0 worst - 5 best)




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493997


Contacts
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Contact: Massimo Lazzeri, MD +393391072211 lazzeri.maximus@gmail.com
Contact: Davide Corradengo +393498731588 mistic.protocol@gmail.com

Locations
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Italy
Ospedali Careggi Not yet recruiting
Firenze, Italy
Contact: Gianni Vittori         
Principal Investigator: Gianni Vittori, MD         
Università "Vita-Salute" San Raffaele Recruiting
Milano, Italy
Contact: Renzo Colombo         
Principal Investigator: Renzo Colombo, MD         
University of Palermo, Italy Not yet recruiting
Palermo, Italy
Contact: Vincenzo Serretta         
Principal Investigator: Vincenzo Serretta, MD         
Slovakia
St. Cyril and Method University Hospital Recruiting
Bratislava, Slovakia
Contact: Martin Romancik         
Principal Investigator: Martin Romancik, MD         
Fakultná nemocnica s poliklinikou Recruiting
Prešov, Slovakia
Contact: Richard Lunik, MD         
Principal Investigator: Richard Lunik, MD         
Spain
Universidad Autónoma de Barcelona Recruiting
Barcelona, Spain
Contact: Francesco Sanguedolce, MD       fsanguedol@fundacio-puigvert.es   
Principal Investigator: Francesco Sanguedolce         
Turkey
Istanbul University Recruiting
Istanbul, Turkey
Contact: Bulent Cetinel         
Principal Investigator: Bulent Cetinel, MD         
Sponsors and Collaborators
Study Group for Urogenital Diseases, Italy
Investigators
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Study Director: Massimo LAzzeri, MD Gruppo di Studio per le Malattie Urogenitali

Publications:
Cervigni M, Sommariva M, Porru D, Ostardo E, Tenaglia R, Giammò A, et al. A randomized, open-label, multicentre study of efficacy and safety of intravesical hyaluronic acid and chondroitin sulfate (HA 1.6% and CS 2%) vs dimethyl sulfoxide (DMSO 50%) in women with Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC). Eur Urol Suppl 2014;13(1):e464.
Cervigni M, Van Kerrebroeck PE, Dinis Oliveira P, Tarricone R, Guzman SA. Glycosaminoglycan-Replenishment Therapy: rationale for use and current evidence. EMJ Urol. 2014;1:41-47.
Nordling J. Bladder Pain Syndrome/ Interstitial Cystitis. Update in Europe. International Journal of Urology 2014;21(Supplement S1):A1-A11.
Mottet N, Bastian PJ, Bellmunt J, van den Bergh RCN, Bolla M, van Casteren NJ, et al. Guidelines on Prostate Cancer. Uroweb 2014.

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Responsible Party: Study Group for Urogenital Diseases, Italy
ClinicalTrials.gov Identifier: NCT03493997     History of Changes
Other Study ID Numbers: MISTIC
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystitis
Urinary Bladder Diseases
Urologic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents