Non-Muscle-invasive Bladder Cancer (NMIBC) Clinical Trial
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
Compare the different supposed clinical treatment of side effects associated with intravesical BCG by levofloxacin (quinolones) vs solifenacin (selective anti-muscarinic) vs lornoxicam (NSAID)
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06186414 -
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination With BCG in NMIBC
|
Phase 1 | |
| Recruiting |
NCT06351904 -
A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy
|
Phase 1 |