Recruiting

Curcumin with Exosomes

Sponsor:

University of Louisville

Code:

NCT01294072

Conditions

Colon Cancer

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

Interventions

curcumin

Curcumin conjugated with plant exosomes

No intervention

Study Details

Brief summary:

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

Colon Cancer

Study ID

NCT01294072

Start date

Jan, 2011

Status verified date

Dec, 2023

Completion date

Nov, 2024

Anticipated

Primary completion date

Nov, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Arm 1: Curcumin alone

Subjects take curcumin orally.

experimental: Arm 2: Curcumin with plant exosomes

Subjects take curcumin conjugated with plant exosomes.

experimental: Arm 3: no treatment

subjects will not take curcumin or plant exosomes

Interventions

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

Primary outcome measure

  • Concentration of curcumin in normal and cancerous tissue [ Time Frame: 7 days after start of curcumin ingestion ]

Central Contacts and Locations

Central contacts

Gerald W Dryden Jr, MD, Ph.D

502-852-6991gerald.dryden@louisville.edu

Locations

University of Louisville Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Principal Investigator:

Gerald W Dryden, MD, Ph.D

More Information

Sponsor

University of Louisville

Last update posted

Dec 20, 2023

Last verified

Dec, 2023

Keywords

  • curcumin
  • plant exosomes
  • malignant colon tissue

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2023-12-20.