Clinical trial · Interventional
LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder
LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder - Phase IIA Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-muscle Invasive Bladder Cancer (NMIBC) | Non-Muscle Invasive Bladder Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LCS103 | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LCS103 + Standard of Care
- description
- Patients in the investigational arm will receive 1-year bidaily 3 oral tablets of LCS103 herbal formula, in addition to the SOC recommended per risk group
- interventionNames
- Dietary Supplement: LCS103
- type
- NO_INTERVENTION
- label
- Standard of Care Alone
- description
- Participants in the control arm will receive SOC-recommended treatment according to risk group
Primary outcomes (1)
- measure
- LCS103 Safety: Incidence and Severity of Treatment-Emergent Adverse Events, Graded by CTCAE v5.0
- timeFrame
- During the 1-year LCS103 administration period.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDMaimon Y, Amiel G, Cohen Z, Hoffman A, Samuels N. Prevention of Bladder Cancer Recurrence With the Botanical Formula LCS103: A Case Series Study. Integr Cancer Ther. 2024 Jan-Dec;23:15347354241233233. doi: 10.1177/15347354241233233. PMID 38362870
- BACKGROUNDMaimon Y, Samuels N, Cohen Z, Berger R, Rosenthal DS. Botanical Formula LCS101: A Multi-Targeted Approach to Cancer Care. Integr Cancer Ther. 2018 Dec;17(4):1020-1026. doi: 10.1177/1534735418801528. Epub 2018 Oct 10. PMID 30303021
- BACKGROUNDCragg GM, Newman DJ. Plants as a source of anti-cancer agents. J Ethnopharmacol. 2005 Aug 22;100(1-2):72-9. doi: 10.1016/j.jep.2005.05.011. PMID 16009521
- BACKGROUNDYates JS, Mustian KM, Morrow GR, Gillies LJ, Padmanaban D, Atkins JN, Issell B, Kirshner JJ, Colman LK. Prevalence of complementary and alternative medicine use in cancer patients during treatment. Support Care Cancer. 2005 Oct;13(10):806-11. doi: 10.1007/s00520-004-0770-7. Epub 2005 Feb 15. PMID 15711946
- BACKGROUNDAntoni S, Ferlay J, Soerjomataram I, Znaor A, Jemal A, Bray F. Bladder Cancer Incidence and Mortality: A Global Overview and Recent Trends. Eur Urol. 2017 Jan;71(1):96-108. doi: 10.1016/j.eururo.2016.06.010. Epub 2016 Jun 28. PMID 27370177
- BACKGROUNDMatulewicz RS, Steinberg GD. Non-muscle-invasive Bladder Cancer: Overview and Contemporary Treatment Landscape of Neoadjuvant Chemoablative Therapies. Rev Urol. 2020;22(2):43-51. PMID 32760227
- BACKGROUNDSiegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763. PMID 36633525