RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2011-01
Study Completion:2024-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01294072

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.

Ages Eligible for Study:20 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects must have definitive diagnosis of colon cancer.
  2. * Surgical resection of the primary tumor must be an option for the newly diagnosed cancer.
  3. * No history of diabetes
  4. * 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.
  5. * Absence of life-limiting medical conditions
  6. * Ability to understand and willingness to sign a written informed consent document.
  7. * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Karnofsky \> 60%; see Appendix A).
  8. * Subjects must have adequate bone marrow function. ANC \> 1000/microliters (microL) and Platelet count \>100,000/microL
  9. * Age \>20 years
  1. * Known familial colon cancer syndrome
  2. * Pregnancy
  3. * Known Human Immunodeficiency Virus (HIV)
  4. * Patients receiving immunosuppressive drugs
  5. * Inflammatory bowel disease
  6. * Active second malignancy in the last 5 years
  7. * Patients receiving any other investigational agent(s)
  8. * Patients who have received any prior chemotherapy or radiation therapy to the primary colon cancer
  9. * Intolerance to grapes, grapefruit, or curcumin
  10. * History of diabetes mellitus

Contacts and Locations

Study Contact

Gerald W Dryden Jr, MD, Ph.D
CONTACT
502-852-6991
gerald.dryden@louisville.edu

Principal Investigator

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

Study Locations (Sites)

University of Louisville Hospital
Louisville, Kentucky, 40202
United States

Collaborators and Investigators

Sponsor: University of Louisville

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2011-01
Study Completion Date2024-11

Study Record Updates

Study Start Date2011-01
Study Completion Date2024-11

Terms related to this study

Keywords Provided by Researchers

  • curcumin
  • plant exosomes
  • malignant colon tissue

Additional Relevant MeSH Terms

  • Colon Cancer