Solifenacin, Levofloxacin or Lornoxicam, Which Is Ideal for Management of Intravesical Instillation BCG Side Effects?

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03038321
• Other study ID #: R/17.01.02
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 15, 2017
• Last updated: May 19, 2017
• Start date: February 1, 2017
• Est. completion date: December 2019

Study information

• Verified date: March 2017
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compare the different supposed clinical treatment of side effects associated with intravesical BCG by levofloxacin (quinolones) vs solifenacin (selective anti-muscarinic) vs lornoxicam (NSAID)

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients classified as intermediate or high risk of the bladder tumour

Exclusion Criteria:

• Patient over 80 years (natural decline in immune system function)

• Refuse to complete study requirements

• Contraindication to BCG therapy

• High post-void residual (PVR) above 85 ml

• American Urological Association (AUA) Symptoms score above 20

• Sensitivity to previously mentioned 3 drugs

• High serum creatinine

Related Conditions & MeSH terms

• Bacillus Calmette-Guerin (BCG) Cystitis
• Cystitis
• Intra-vesical Instillation
• Non-Muscle-invasive Bladder Cancer (NMIBC)
• Urinary Bladder Neoplasms

Intervention

Drug:
• sofenacin
solifenacin 10 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation
• Tavanic
levofloxacin 500 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation.
• Xefo
lornoxicam 8 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation.

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center	Mansoura	Aldakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing the drugs efficacy on decreasing systemic and local side effects of BCG	__ Outcome Measure by Four-class classification grid of BCG adverse events	6 weeks
Secondary	Comparing the drugs effect on decreasing voiding and storage urinary symptoms of BCG	__ Outcome Measure by overactive bladder symptoms scores and American Urological Association Symptom Index	6 weeks
Secondary	Prostatic specific antigen (PSA) change	__ Outcome Measure by PSA measure 1 and 3 months post instillation	1 month and 3 months
Secondary	recurrence free survival	__ Outcome Measure by Number of patients surviving for one year without tumor recurrence will be counted and compared	1 year