LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLifeBiotic Medical Research Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
LCS103
Dietary supplementLCS103 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: LCS103 + Standard of CareExperimental treatment 1 intervention
Group B: Standard of Care AloneNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
LCS103 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.Secondary outcomes
1
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 period2
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 period3
Bladder cancer stage or grade progression at 1 year
Time frame
Baseline to the end of the 1-year study follow-up period4
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 periodSponsors and contacts
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Source ClinicalTrials.gov