Solifenacin, Levofloxacin or Lornoxicam, Which Is Ideal for Management of Intravesical Instillation BCG Side Effects?
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|ClinicalTrials.gov Identifier: NCT03038321|
Recruitment Status : Unknown
Verified March 2017 by Abdelwahab Hashem, Mansoura University.
Recruitment status was: Active, not recruiting
First Posted : January 31, 2017
Last Update Posted : May 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non-Muscle-invasive Bladder Cancer (NMIBC) Bacillus Calmette-Guerin (BCG) Cystitis Intra-vesical Instillation||Drug: sofenacin Drug: Tavanic Drug: Xefo||Phase 4|
For urothelial carcinoma (UC), which accounts for over 90% of bladder cancers, more than 70% of bladder cancer patients present with non‐muscle‐invasive disease. Approximately 40-80% of these tumors will recur within the first year, of which 10-25% will progress to muscle‐invasive disease.
Intravesical treatments with cytotoxic chemotherapy and immunotherapy have become the mainstay following transurethral resection (TUR). Increasing knowledge of BCG use allows for effective management of these once debilitating side effects. The majority of patients will still experience cystitis‐like symptoms to some degree, including urinary frequency (71%), cystitis (67%), fever (25%), and hematuria (23%).
Oxybutynin increases in fever, flu-like symptoms, dry mouth and constipation. However, in this study oxybutynin started the night before treatment causing an element of incomplete bladder emptying and allowing an increased BCG dwell time. We think that these effect can be reversed by use anticholinergic 6 hours post BCG instillation Anti-inflammatory drugs significantly reduced BCG-induced granulocyte activation and did not impair BCG-induced lymphocyte cytotoxicity against bladder tumor cells in mice. The committee of International Bladder Cancer Group (IBCG) recommend use of anti-inflammatory agents (NSAIDs) for treatment of non-bacterial or chemical cystitis and other systemic BCG side effect.
Fluoroquinolone with tuberculostatic properties, has been shown to significantly prolong survival in mice with BCG systemic infection and did not affect the antitumor efficacy of BCG. ofloxacin significantly decreased by 18.5% the incidence of class II or higher moderate and severe adverse events of BCG.
Because of sparse published studies on BCG side effect management, the 2016 European Association of Urology (EAU) guidelines management options for side effects associated with intravesical BCG modify the IBCG committee clinical practice without any degree of recommendation. So, in this study the investigators will try to fill the gap in the literature.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Solifenacin vs Levofloxacin vs Lornoxicam for Management of Intravesical Instillation of Bacillus Calmette-Guerin (BCG) Side Effects A Single Blinded Randomised Controlled Study|
|Actual Study Start Date :||February 1, 2017|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2019|
Active Comparator: solifenacin
(Sofenacin ''solifenacin 10 m'') [Marcyrl Pharmaceutical Industries - Egypt]
solifenacin 10 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation
Other Name: Solfenacin 10 mg
Active Comparator: levofloxacin
(Tavanic ''levofloxacin 500 mg'') [Sanofi-Aventis - Egypt]
levofloxacin 500 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation.
Other Name: levofloxacin 500
Active Comparator: lornoxicam
(Xefo ''lornoxicam 8 mg'') [Multi-Apex - Egypt, under license of: NYCOMED, Austria]
lornoxicam 8 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation.
Other Name: lornoxicam
- Comparing the drugs efficacy on decreasing systemic and local side effects of BCG [ Time Frame: 6 weeks ]__ Outcome Measure by Four-class classification grid of BCG adverse events
- Comparing the drugs effect on decreasing voiding and storage urinary symptoms of BCG [ Time Frame: 6 weeks ]__ Outcome Measure by overactive bladder symptoms scores and American Urological Association Symptom Index
- Prostatic specific antigen (PSA) change [ Time Frame: 1 month and 3 months ]__ Outcome Measure by PSA measure 1 and 3 months post instillation
- recurrence free survival [ Time Frame: 1 year ]__ Outcome Measure by Number of patients surviving for one year without tumor recurrence will be counted and compared
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): NCT03038321
|Urology and Nephrology Center|
|Mansoura, Aldakahlia, Egypt, 35516|
|Study Chair:||Hassan Abol-Enein, MD, Phd||Urology and Nephrology Center|
|Study Director:||Ahmed Mosbah, MD||Urology and Nephrology Center|
|Principal Investigator:||Ahmed Elhussein, MBBCH||Urology and Nephrology Center|
|Principal Investigator:||Ahmed Elkarta, MBBCH||Urology and Nephrology Center|
|Principal Investigator:||Mohamed Soltan||Urology and Nephrology Center|