Clinical trial · Interventional
Study Investigating the Ability of Plant Exosomes to Deliver Curcumin to Normal and Colon Cancer Tissue
Phase I Clinical Trial Investigating the Ability of Plant Exosomes to Deliver Curcumin to Normal and Malignant Colon Tissue
- 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 clinical trial will investigate the ability of plant exosomes to more effectively deliver curcumin to normal colon tissue and colon tumors. Curcumin is the yellow pigment of turmeric, a natural product with diverse biological activities. Exosomes are small endosome-derived vesicles (50-100 nanometers \[nm\] in size). Previous clinical trials conducted with oral curcumin have demonstrated only limited bioavailability even at very high doses of 8-12 grams per day. This trial plans to address this problem of curcumin delivery by using plant exosomes to deliver the drug to colon tumors and normal colon tissue.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| curcumin | Dietary Supplement | — | UNRESOLVED |
| Curcumin conjugated with plant exosomes | Dietary Supplement | — | UNRESOLVED |
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1: Curcumin alone
- description
- Subjects take curcumin orally.
- interventionNames
- Dietary Supplement: curcumin
- type
- EXPERIMENTAL
- label
- Arm 2: Curcumin with plant exosomes
- description
- Subjects take curcumin conjugated with plant exosomes.
- interventionNames
- Dietary Supplement: Curcumin conjugated with plant exosomes
- type
- EXPERIMENTAL
- label
- Arm 3: no treatment
- description
- subjects will not take curcumin or plant exosomes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWu 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. PMID 29054476