Journal of Cancer Research
- ISSN: 2578-3726
Alexandre Tavartkiladze, Gaiane Simonia, Russel J Reiter, Ruite Lou, Nana Okrostsvaridze, Pati Revazishvili, Givi Tavartkiladze and Malvina Javakhadze
Background: Metastatic colorectal cancer (mCRC) remains a significant global health challenge, with high incidence and mortality rates. Current therapies, including chemotherapy, targeted agents, and immunotherapy, face challenges such as multidrug resistance (MDR), severe toxicity, and limited efficacy. AminoSineTriComplex, a novel natural therapeutic integrating bioactive compounds derived from medicinal plants and advanced nanotechnology, was evaluated for its safety and efficacy as an adjunct treatment for mCRC.
Methods: This double-blind, placebo-controlled randomized clinical trial enrolled 72 patients with histologically confirmed mCRC across three oncology centers. Participants were randomized 1:1 to receive either AminoSineTriComplex (6–8 capsules/ day) or placebo for 12 weeks. Primary endpoints included tumor response rates per RECIST v1.1 criteria. Secondary endpoints assessed changes in biomarkers (LDH-5, IL-6, CEA, CA19.9), progression-free survival (PFS), and quality of life (QoL). Circadian biology was explored through serum melatonin levels measured at four time points (06:00 AM, 12:00 PM, 09:00 PM, 02:00 AM) and 24-hour urinary melatonin sulfate levels. Statistical analyses were performed using SPSS (v26).
Results: AminoSineTriComplex demonstrated superior efficacy compared to placebo, with complete remission observed in 42% of patients and partial remission in 11% (placebo: 8% and 4%, respectively; p<0.001). Significant reductions in biomarkers were noted in the AminoSineTriComplex group: LDH-5 (42%, p<0.001), IL-6 (58%, p<0.001), CEA (41%, p=0.01), and CA19.9 (40%, p=0.02). Patients with well-maintained circadian rhythms, characterized by synchronized melatonin secretion and robust nocturnal peaks, exhibited improved treatment responses. Among complete responders, 93% had normal melatonin patterns, while 78% of those with disease progression exhibited disrupted rhythms (p<0.001).
Safety: AminoSineTriComplex was well-tolerated, with no grade ≥3 adverse events reported. Mild gastrointestinal discomfort occurred in 11% of patients, with no significant toxicities or treatment discontinuations.
Conclusion: AminoSineTriComplex offers a promising, non-toxic adjunct therapy for mCRC, demonstrating efficacy in reducing tumor burden, modulating biomarkers, and restoring circadian rhythms. Its favorable safety profile and integration with circadian biology highlight its potential in personalized cancer care. Further multi-center trials are warranted to confirm these findings and explore its long-term clinical applications.