Using plant exosomes to deliver curcumin for colon cancer treatment
Phase I Clinical Trial Investigating the Ability of Plant Exosomes to Deliver Curcumin to Normal and Malignant Colon Tissue
This study is testing if using plant-based tiny particles can help deliver curcumin, a natural compound that may fight colon cancer, more effectively to improve treatment results for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT01294072 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of plant exosomes in delivering curcumin, a natural compound with potential anti-cancer properties, to both normal colon tissue and colon tumors. Curcumin has shown promise in inhibiting colon cancer growth, but its clinical use has been limited due to poor bioavailability. By utilizing plant-derived exosomes, the study aims to enhance the stability, solubility, and absorption of curcumin in the body. Participants will be monitored for the impact of this novel delivery method on colon cancer treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 20 years old with a definitive diagnosis of colon cancer who are eligible for surgical resection.
Not a fit: Patients with known familial colon cancer syndromes or those with active second malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the delivery and effectiveness of curcumin in treating colon cancer.
How similar studies have performed: While the use of exosomes for drug delivery is a growing field, this specific application of plant exosomes for curcumin delivery in colon cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects must have definitive diagnosis of colon cancer. * Surgical resection of the primary tumor must be an option for the newly diagnosed cancer. * No history of diabetes * Subjects must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines. * Absence of life-limiting medical conditions * Ability to understand and willingness to sign a written informed consent document. * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Karnofsky \> 60%; see Appendix A). * Subjects must have adequate bone marrow function. ANC \> 1000/microliters (microL) and Platelet count \>100,000/microL * Age \>20 years Exclusion Criteria: * Known familial colon cancer syndrome * Pregnancy * Known Human Immunodeficiency Virus (HIV) * Patients receiving immunosuppressive drugs * Inflammatory bowel disease * Active second malignancy in the last 5 years * Patients receiving any other investigational agent(s) * Patients who have received any prior chemotherapy or radiation therapy to the primary colon cancer * Intolerance to grapes, grapefruit, or curcumin * History of diabetes mellitus
Where this trial is running
Louisville, Kentucky
- University of Louisville Hospital — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Gerald W Dryden Jr, MD, PhD — University of Louisville
- Study coordinator: Gerald W Dryden Jr, MD, Ph.D
- Email: gerald.dryden@louisville.edu
- Phone: 502-852-6991
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.