None listed
Conditions
Brief summary
This pilot study will investigate effect of oral adjuncts Mirabegron and Phenazopyridine Hydrochloride given during intravesical Bacillus Calmette-Guerin (BCG) therapy for non muscle invasive bladder cancer Who is it for? You may be eligible to join this study if you are aged 18 years or above and diagnosed with non muscle invasive bladder cancer and have planned intravesical BCG therapy Study details Participants in this study will randomly allocated (by chance) to one of three groups: one group will take Mirabegron once daily for 6 weeks throughout your course of treatment, another group will take Phenazopyridine Hydrochloride three times daily with or without food for 6 weeks throughout your course of treatment, and placebo orally once daily for the 6 weeks throughout your course of treatment. Quality of life will be assessed using questionnaires at regular intervals for the duration of your course of treatment, and a further week after it concludes. Adverse events and treatment discontinuation will also be assessed. This research is expected to identify effective oral therapies that reduce BCG-related bladder side effects, with the aim of improving patients’ quality of life and supporting completion of their cancer-preventing intravesical BCG treatment.
Interventions
Arm 1: Mirabegron
Type administered: Oral tablet.
Dose and schedule: Mirabegron 50 mg taken once daily.
Duration of administration: From the first day of intravesical BCG therapy until 7 days after the final BCG instillation in that treatment cycle.
Timing relative to BCG: Participants commence mirabegron on the same day that intravesical BCG therapy begins.
Adherence monitoring: Adherence will be assessed by prescription records and by participant self-report recorded alongside weekly questionn
Arm 1: Mirabegron Type administered: Oral tablet. Dose and schedule: Mirabegron 50 mg taken once daily. Duration of administration: From the first day of intravesical BCG therapy until 7 days after the final BCG instillation in that treatment cycle. Timing relative to BCG: Participants commence mirabegron on the same day that intravesical BCG therapy begins. Adherence monitoring: Adherence will be assessed by prescription records and by participant self-report recorded alongside weekly questionnaires. Arm 2: Phenazopyridine Hydrochloride Type administered: Oral tablet. Dose and schedule: Phenazopyridine Hydrochloride 200 mg taken three times daily (morning, midday, evening) with or without food Duration of administration: From the first day of intravesical BCG therapy until 7 days after the final BCG instillation in that treatment cycle. Timing relative to BCG: Participants commence phenazopyridine on the same day that intravesical BCG therapy begins. Adherence monitoring: Adherence will be assessed by prescription records and by participant self-report recorded alongside weekly questionnaires.
Sponsors
SALHN
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
· Patients diagnosed with non muscle invasive bladder cancer (NMIBCE) (with histopathology of Tis, Ta, T1) · Adult patients >17 years old · Planned for intravesical BCG therapy as deemed by treating clinician · BCG Naïve patients
Exclusion criteria
· Previous withdrawal from BCG treatment due to intolerance · Current active lower urinary tract symptoms · Using antimuscarinics or non-steroidal anti-inflammatory medications · Contraindications for mirabegron (uncontrolled hypertension) · Contraindications for phenazopyradine (renal impairment)
Outcome results
None listed