Study Investigating the Ability of Plant Exosomes to Deliver Curcumin to Normal and Colon Cancer Tissue
NCT ID: NCT01294072
Last Updated: 2023-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
35 participants
INTERVENTIONAL
2011-01-31
2024-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Work from the James Graham Brown Cancer Center published recently suggests that using exosomes as a delivery vehicle leads to overcoming all the major obstacles of using curcumin as an anti-inflammatory agent, including increased stability, solubility, and bioavailability of curcumin. The work was further extended to define the resource that can supply a large quantity of exosomes with a maximum binding capacity of curcumin. Emerging data indicate that exosomes derived from many fruits release exosome-like particles, strongly bind to many hydrophobic drugs including curcumin, and are taken up by the intestine cells as well as the immune cells in the intestine. These results suggest that these fruit-derived exosomes are potentially used as a delivery vehicle to treatment of intestinal diseases. Moreover, both fruit exosomes and curcumin should not generate any side-effects since they are consumed by humans daily.
In this clinical trial, the effect of exosomally delivered curcumin on the immune modulation, cellular metabolism, and phospholipid profile of normal and malignant colon cells in subjects who are undergoing surgery for newly diagnosed colon cancer will be characterized. In selected subjects, the effect of exosomally delivered curcumin on the production of cytokines, the changes of immune cells, and glucose metabolism by administration of 13C-glucose prior to surgical resection will also be characterized.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1: Curcumin alone
Subjects take curcumin orally.
curcumin
tablets-3.6 gram (gm) taken daily for 7 days - 15 subjects
Arm 2: Curcumin with plant exosomes
Subjects take curcumin conjugated with plant exosomes.
Curcumin conjugated with plant exosomes
tablets-taken daily for 7 days - 15 subjects
Arm 3: no treatment
subjects will not take curcumin or plant exosomes
No intervention
no treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
curcumin
tablets-3.6 gram (gm) taken daily for 7 days - 15 subjects
Curcumin conjugated with plant exosomes
tablets-taken daily for 7 days - 15 subjects
No intervention
no treatment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Louisville
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gerald W. Dryden, Jr.
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gerald W Dryden Jr, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Louisville Hospital
Louisville, Kentucky, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Wu K, Xing F, Wu SY, Watabe K. Extracellular vesicles as emerging targets in cancer: Recent development from bench to bedside. Biochim Biophys Acta Rev Cancer. 2017 Dec;1868(2):538-563. doi: 10.1016/j.bbcan.2017.10.001. Epub 2017 Oct 18.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BCC-GI-10 Curcumin
Identifier Type: -
Identifier Source: org_study_id