LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder

Официальное название

LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder - Phase IIA Randomized Controlled Trial

Обзор

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.

Вмешательства

• Пищевая добавка LCS103
  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.

Первичные конечные точки

• LCS103 Safety: Incidence and Severity of Treatment-Emergent Adverse Events, Graded by CTCAE v5.0 [Срок оценки: During the 1-year LCS103 administration period.]

Вторичные конечные точки (11)

• Percentage of Prescribed LCS103 Tablets Consumed, Based on Pill Count [Срок оценки: During the 1-year study administration period]
• Bladder cancer recurrence at 1 year [Срок оценки: During the 1-year study administration period]
• Bladder cancer stage or grade progression at 1 year [Срок оценки: Baseline to the end of the 1-year study follow-up period]
• Change in urinary symptom severity (IPSS) [Срок оценки: 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) [Срок оценки: Baseline to the end of the 1-year study follow-up period]
• Change in erectile function - male participants only (IIEF-EF) [Срок оценки: Baseline to the end of the 1-year study follow-up period]
• Change in serum C-reactive protein (CRP) [Срок оценки: Baseline to the end of the 1-year study follow-up period]
• Change in neutrophil-to-lymphocyte ratio (NLR) [Срок оценки: Baseline to the end of the 1-year study follow-up period]
• Change in urinary leucocyte count (leucocyturia) [Срок оценки: 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. [Срок оценки: Baseline to the end of the 1-year study follow-up period]
• Change in maximum urinary flow rate (Qmax) - from uroflowmetry. [Срок оценки: Baseline to the end of the 1-year study follow-up period]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Израиль · 1 центр

• Rambam Health Care Campus, Urology Department — Haifa

Публикации

• Maimon 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
• Maimon 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
• Cragg 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
• Yates 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
• Antoni 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
• Matulewicz 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
• Siegel 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

Идентификаторы

NCT: NCT07728474 · 0424-24-RMB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗