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

NCT01294072 | Unknown DMC

• 1 other identifier: BCC-GI-10 Curcumin
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Keywords

curcumin; plant exosomes; malignant colon tissue

Outcome Measures

Primary Outcomes (1)

• Concentration of curcumin in normal and cancerous tissue

  Concentration of curcumin delivered with curcumin alone or curcumin conjugated with plant exosomes to normal and cancerous colon cells will be compared. This exploratory trial is designed to estimate the effect of a fixed concentration of curcumin when delivered by plant exosomes compared to oral tablets of curcumin alone.

  7 days after start of curcumin ingestion

Secondary Outcomes (7)

• safety and tolerability of curcumin alone as determined by adverse events

  7 days after study enrollment

• effects of curcumin on normal and cancerous colon cells by measuring the biomarkers using histochemical staining

  7 days after patient enrollment

• the immune system response to curcumin, measured by serum cytokine levels

  7 days after patient enrollment in study

• immune response in ex vivo cell cultures of colon cancer cells treated with curcumin and Exo-cur, to be evaluated by using histochemical staining

  7 days after patient enrollment in study

• measurement of curcumin alone on metabolic characteristics of normal colon mucosa and colon tumors

  7 days after patient enrollment

Study Arms (3)

Arm 1: Curcumin alone

EXPERIMENTAL

Subjects take curcumin orally.

Dietary Supplement: curcumin

Arm 2: Curcumin with plant exosomes

EXPERIMENTAL

Subjects take curcumin conjugated with plant exosomes.

Dietary Supplement: Curcumin conjugated with plant exosomes

Arm 3: no treatment

EXPERIMENTAL

subjects will not take curcumin or plant exosomes

Other: No intervention

Interventions

curcumin DIETARY_SUPPLEMENT

tablets-3.6 gram (gm) taken daily for 7 days - 15 subjects

Arm 1: Curcumin alone

Curcumin conjugated with plant exosomes DIETARY_SUPPLEMENT

tablets-taken daily for 7 days - 15 subjects

Arm 2: Curcumin with plant exosomes

No intervention OTHER

no treatment

Arm 3: no treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 29054476 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Gerald W Dryden Jr, MD, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerald W Dryden Jr, MD, Ph.D

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: curcumin alone in capsule form (Arm 1) curcumin combined with plant exosomes (Arm 2) will not take curcumin or plant exosomes (Arm 3)

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 11, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

US (1)