Non-muscle Invasive Bladder Cancer (NMIBC)
Conditions
Keywords
NMIBC, Bladder Cancer, Non-Muscle Invasive Bladder Cancer
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTLCS103
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.
Sponsors
LifeBiotic Medical Research Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a randomized, parallel-assignment, open-label trial. Participants will be randomized in a 1:1 ratio to either the investigational (LCS103) or control arm (Standard of Care), with randomization stratified by EAU risk group (low, intermediate, and high risk).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women aged ≥ 18 years. * Non-muscle invasive urothelial carcinoma, histologically confirmed by TURBT procedure within 3 months before enrollment. * Complete resection of bladder tumor in recent TURBT.
Exclusion criteria
* Inability to provide informed consent. * Inability to swallow tablets (esophageal stricture, feeding through gastrostomy). * Ineligibility for SOC therapy such as BCG instillations (where appropriate). * Upper tract urothelial carcinoma within the past 2 years. * Any malignancy other than NMIBC, active or systemically treated within the past 2 years (not including localized cutaneous basal cell or squamous cell carcinoma). * Estimated life expectancy \< 5 years. * Pregnant women, and women planning future pregnancy or wishing to preserve fertility. * Investigator evaluation of a physical or mental condition limiting a patient's ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LCS103 Safety: Incidence and Severity of Treatment-Emergent Adverse Events, Graded by CTCAE v5.0 | During the 1-year LCS103 administration period. | Incidence and severity of treatment-associated adverse events according to CTCAE v5.0 grading system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Prescribed LCS103 Tablets Consumed, Based on Pill Count | During the 1-year study administration period | 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. |
| Bladder cancer recurrence at 1 year | During the 1-year study administration period | Bladder cancer recurrence at 1 year, defined as suspicious cystoscopic findings, malignant cells in urine cytology, or positive bladder biopsy. |
| Bladder cancer stage or grade progression at 1 year | Baseline to the end of the 1-year study follow-up period | — |
| Change in urinary symptom severity (IPSS) | Baseline to the end of the 1-year study follow-up period | 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 |
| Change in overall health-related quality of life (EQ-5D-5L/EQ-VAS) | Baseline to the end of the 1-year study follow-up period | 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 |
| Change in erectile function - male participants only (IIEF-EF) | Baseline to the end of the 1-year study follow-up period | 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 |
| Change in serum C-reactive protein (CRP) | Baseline to the end of the 1-year study follow-up period | Serum C-reactive protein (CRP) concentration is measured on routine blood chemistry. Unit of Measure: mg/dL Range: 0-0.5 |
| Change in neutrophil-to-lymphocyte ratio (NLR) | Baseline to the end of the 1-year study follow-up period | Neutrophil-to-lymphocyte ratio (NLR) is calculated from the complete blood count (absolute neutrophils divided by absolute lymphocytes). Unit of Measure: Ration |
| Change in urinary leucocyte count (leucocyturia) | Baseline to the end of the 1-year study follow-up period | Urinary leucocyte count is measured on routine urinalysis. Unit of Measure: Leu/µL Range: Negative, 25 Leu/µL |
| Change in tongue appearance - a common measure of inflammation in traditional Chinese medicine. | Baseline to the end of the 1-year study follow-up period | 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 |
| Change in maximum urinary flow rate (Qmax) - from uroflowmetry. | Baseline to the end of the 1-year study follow-up period | Maximum urinary flow rate (Qmax) measured by uroflowmetry. Unit of Measure: Millilitres per second (mL/s) |
Countries
Israel
Contacts
CONTACTYair Maimon, Dr.
PRINCIPAL_INVESTIGATOREtan Eigner, MD
Rambam Health Care Campus
Outcome results
None listed