Study Investigating the Ability of Plant Exosomes to Deliver Curcumin to Normal and Colon Cancer Tissue

Description

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

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Study Overview

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Study Details

Study overview

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.

Phase I Clinical Trial Investigating the Ability of Plant Exosomes to Deliver Curcumin to Normal and Malignant Colon Tissue

Study Investigating the Ability of Plant Exosomes to Deliver Curcumin to Normal and Colon Cancer Tissue

Condition
Colon Cancer
Intervention / Treatment

-

Contacts and Locations

Louisville

University of Louisville Hospital, Louisville, Kentucky, United States, 40202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

20 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Louisville,

Gerald W Dryden Jr, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Louisville

Study Record Dates

2024-11