This study is a phase IIA, single-site, randomized, controlled, open-label clinical trial evaluating the safety and efficacy of the LCS103 oral herbal formula for the secondary prevention of NMIBC. The study will include 60 participants randomized 1:1 to either the investigational or control arm. Patients in the investigational arm will receive three oral tablets of LCS103 herbal formula twice daily for 1 year, in addition to the SOC recommended per risk group: * Low Risk: Cystoscopic follow-up at 3 \& 9 months and yearly thereafter. * Intermediate Risk: 1-year intravesical instillations of BCG. Cystoscopic follow-up at 3 \& 9 months, then biannually for 2 years and yearly thereafter. * High Risk: 3-year intravesical instillations of BCG. Cystoscopy and urine cytology every 3 months for 2 years, then biannually thereafter. Participants in the control arm will receive SOC treatment as mentioned above. After 1 year, the investigational treatment will be stopped, and all participants will continue SOC treatment and surveillance. The enrollment period is expected to be 1 year. The study will be terminated after the final visit of the last patient. The total study duration is expected to be 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
LCS103 is an oral botanical dietary supplement composed of multiple herbal extracts. Participants in the investigational arm will receive 3 tablets twice daily for 12 months in addition to the standard of care according to the EAU risk group.
Rambam Health Care Campus, Urology Department
Haifa, Israel
RECRUITINGLCS103 Safety: Incidence and Severity of Treatment-Emergent Adverse Events, Graded by CTCAE v5.0
Incidence and severity of treatment-associated adverse events according to CTCAE v5.0 grading system.
Time frame: During the 1-year LCS103 administration period.
Percentage of Prescribed LCS103 Tablets Consumed, Based on Pill Count
Adherence assessed by LCS103 tablet count at months 3, 6, 9, and 12 (investigational arm only). Adherence percentage calculated as (expected tablets consumed - tablets remaining in returned bottles) / expected tablets consumed × 100, where expected consumption is based on the prescribed dose of 6 tablets/day. Adherence ≥75% is classified as adequate.
Time frame: During the 1-year study administration period
Bladder cancer recurrence at 1 year
Bladder cancer recurrence at 1 year, defined as suspicious cystoscopic findings, malignant cells in urine cytology, or positive bladder biopsy.
Time frame: During the 1-year study administration period
Bladder cancer stage or grade progression at 1 year
Time frame: Baseline to the end of the 1-year study follow-up period
Change in urinary symptom severity (IPSS)
Urination symptom severity is assessed by the International Prostate Symptom Score (IPSS). Unit of Measure: Units on a scale (IPSS total symptom score) Minimum value: 0 Maximum value: 35 Score direction: Higher scores indicate worse urinary symptoms
Time frame: Baseline to the end of the 1-year study follow-up period
Change in overall health-related quality of life (EQ-5D-5L/EQ-VAS)
Health-related quality of life is assessed by the EQ-VAS component of the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). Unit of Measure: Score on the EQ-VAS (self-rated current health) Minimum value: 0 Maximum value: 100 Score direction: Higher scores indicate better self-rated health
Time frame: Baseline to the end of the 1-year study follow-up period
Change in erectile function - male participants only (IIEF-EF)
Erectile function in male participants is assessed by the Erectile Function domain of the International Index of Erectile Function questionnaire (IIEF-EF). Female participants are not assessed. Unit of Measure: Units on a scale (IIEF-EF domain score) Minimum value: 1 Maximum value: 30 Score direction: Higher scores indicate better erectile function
Time frame: Baseline to the end of the 1-year study follow-up period
Change in serum C-reactive protein (CRP)
Serum C-reactive protein (CRP) concentration is measured on routine blood chemistry. Unit of Measure: mg/dL Range: 0-0.5
Time frame: Baseline to the end of the 1-year study follow-up period
Change in neutrophil-to-lymphocyte ratio (NLR)
Neutrophil-to-lymphocyte ratio (NLR) is calculated from the complete blood count (absolute neutrophils divided by absolute lymphocytes). Unit of Measure: Ration
Time frame: Baseline to the end of the 1-year study follow-up period
Change in urinary leucocyte count (leucocyturia)
Urinary leucocyte count is measured on routine urinalysis. Unit of Measure: Leu/µL Range: Negative, 25 Leu/µL
Time frame: Baseline to the end of the 1-year study follow-up period
Change in tongue appearance - a common measure of inflammation in traditional Chinese medicine.
Change in tongue appearance assessed from standardized digital photographs of the tongue, taken at baseline and at the end of the study. Unit of Measure: Photographic comparison
Time frame: Baseline to the end of the 1-year study follow-up period
Change in maximum urinary flow rate (Qmax) - from uroflowmetry.
Maximum urinary flow rate (Qmax) measured by uroflowmetry. Unit of Measure: Millilitres per second (mL/s)
Time frame: Baseline to the end of the 1-year study follow-up period
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