Colon CancerNCT01294072
Study Investigating the Ability of Plant Exosomes to Deliver Curcumin to Normal and Colon Cancer Tissue
A study testing curcumin and Curcumin conjugated with plant exosomes in people with Colon Cancer, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- curcumin and Curcumin conjugated with plant exosomes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Louisville Hospital
Louisville, Kentucky, 40202
Gerald W Dryden, MD, Ph.D
About this study
Official title: Phase I Clinical Trial Investigating the Ability of Plant Exosomes to Deliver Curcumin to Normal and Malignant Colon Tissue
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.
Read the detailed description
Curcumin is a constituent of the spice turmeric, which is one of the primary ingredients of curry powder. Curcumin has been shown to interfere with colon carcinogenesis in a variety of chemical and genetic rodent models. It has also been shown to have a strong inhibitory effect on the growth of colon cancer cell lines. There is considerable evidence that the effects of curcumin are mediated by changes in signal transduction. There is an extensive body of work showing effects on several signaling pathways, including the beta-catenin and NF-κB pathways. Although curcumin has been viewed as an ideal chemopreventative agent in colon cancer for many years, its application has been impeded by important issues with drug delivery and bioavailability in the reported clinical trials of this compound.
Work from the James Graham Brown Cancer Center published recently suggests that using exosomes as a delivery vehicle leads to overcoming all the major obstacles of using curcumin as an anti-inflammatory agent, including increased stability, solubility, and bioavailability of curcumin. The work was further extended to define the resource that can supply a large quantity of exosomes with a maximum binding capacity of curcumin. Emerging data indicate that exosomes derived from many fruits release exosome-like particles, strongly bind to many hydrophobic drugs including curcumin, and are taken up by the intestine cells as well as the immune cells in the intestine. These results suggest that these fruit-derived exosomes are potentially used as a delivery vehicle to treatment of intestinal diseases. Moreover, both fruit exosomes and curcumin should not generate any side-effects since they are consumed by humans daily.
In this clinical trial, the effect of exosomally delivered curcumin on the immune modulation, cellular metabolism, and phospholipid profile of normal and malignant colon cells in subjects who are undergoing surgery for newly diagnosed colon cancer will be characterized. In selected subjects, the effect of exosomally delivered curcumin on the production of cytokines, the changes of immune cells, and glucose metabolism by administration of 13C-glucose prior to surgical resection will also be characterized.
- Conditions
- Colon Cancer
- Being tested
- curcumin, Curcumin conjugated with plant exosomes, No intervention
- Keywords
- curcumin, plant exosomes, malignant colon tissue
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcuminDietary supplement
tablets-3.6 gram (gm) taken daily for 7 days - 15 subjects
Curcumin conjugated with plant exosomesDietary supplement
tablets-taken daily for 7 days - 15 subjects
No interventionOther
no treatment
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Curcumin alone | Experimental | Subjects take curcumin orally. Receives: Dietary Supplement: curcumin |
| Arm 2: Curcumin with plant exosomes | Experimental | Subjects take curcumin conjugated with plant exosomes. Receives: Dietary Supplement: Curcumin conjugated with plant exosomes |
| Arm 3: no treatment | Experimental | subjects will not take curcumin or plant exosomes Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days after start of curcumin ingestion
Secondary outcomes (7)
safety and tolerability of curcumin alone as determined by adverse events
Curcumin will be taken orally.
Measured: 7 days after study enrollment
effects of curcumin on normal and cancerous colon cells by measuring the biomarkers using histochemical staining
Measured: 7 days after patient enrollment
the immune system response to curcumin, measured by serum cytokine levels
Measured: 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
Measured: 7 days after patient enrollment in study
measurement of curcumin alone on metabolic characteristics of normal colon mucosa and colon tumors
Measured: 7 days after patient enrollment
safety and tolerability of curcumin with plant exosomes as determined by adverse events
Curcumin and plant exosomes will be taken orally.
Measured: 7 days after study enrollment
measurement of curcumin mixed with plant exosomes on metabolic characteristics of normal colon mucosa and colon tumors
Measured: 7 days after patient enrollment on study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- curcumin alone in capsule form (Arm 1) curcumin combined with plant exosomes (Arm 2) will not take curcumin or plant exosomes (Arm 3)
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerald W. Dryden, Jr., University of Louisville
- Investigators
- Gerald W Dryden Jr, MD, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294072
- Sponsor's protocol ID
- BCC-GI-10 Curcumin
- Status last verified
- Dec 2023
- First submitted
- 3 Feb 2011
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29054476
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial Investigating the Ability of Plant Exosomes to Deliver Curcumin to Normal and Malignant Colon Tissue
- ClinicalTrials.gov ID
- NCT01294072
- Acronym / sponsor ID
- BCC-GI-10 Curcumin
- Conditions
- Colon Cancer
- Keywords
- curcumin, plant exosomes, malignant colon tissue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Curcumin is a constituent of the spice turmeric, which is one of the primary ingredients of curry powder. Curcumin has been shown to interfere with colon carcinogenesis in a variety of chemical and genetic rodent models. It has also been shown to have a strong inhibitory effect on the growth of colon cancer cell lines. There is considerable evidence that the effects of curcumin are mediated by changes in signal transduction. There is an extensive body of work showing effects on several signaling pathways, including the beta-catenin and NF-κB pathways. Although curcumin has been viewed as an ideal chemopreventative agent in colon cancer for many years, its application has been impeded by important issues with drug delivery and bioavailability in the reported clinical trials of this compound.
Work from the James Graham Brown Cancer Center published recently suggests that using exosomes as a delivery vehicle leads to overcoming all the major obstacles of using curcumin as an anti-inflammatory agent, including increased stability, solubility, and bioavailability of curcumin. The work was further extended to define the resource that can supply a large quantity of exosomes with a maximum binding capacity of curcumin. Emerging data indicate that exosomes derived from many fruits release exosome-like particles, strongly bind to many hydrophobic drugs including curcumin, and are taken up by the intestine cells as well as the immune cells in the intestine. These results suggest that these fruit-derived exosomes are potentially used as a delivery vehicle to treatment of intestinal diseases. Moreover, both fruit exosomes and curcumin should not generate any side-effects since they are consumed by humans daily.
In this clinical trial, the effect of exosomally delivered curcumin on the immune modulation, cellular metabolism, and phospholipid profile of normal and malignant colon cells in subjects who are undergoing surgery for newly diagnosed colon cancer will be characterized. In selected subjects, the effect of exosomally delivered curcumin on the production of cytokines, the changes of immune cells, and glucose metabolism by administration of 13C-glucose prior to surgical resection will also be characterized.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- curcumin alone in capsule form (Arm 1) curcumin combined with plant exosomes (Arm 2) will not take curcumin or plant exosomes (Arm 3)
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Curcumin alone | Experimental | Dietary Supplement: curcuminSubjects take curcumin orally. |
| Arm 2: Curcumin with plant exosomes | Experimental | Dietary Supplement: Curcumin conjugated with plant exosomesSubjects take curcumin conjugated with plant exosomes. |
| Arm 3: no treatment | Experimental | Other: No interventionsubjects will not take curcumin or plant exosomes |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- Known familial colon cancer syndrome
- Pregnancy
- Known Human Immunodeficiency Virus (HIV)
- Patients receiving immunosuppressive drugs
- Inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| curcumintablets-3.6 gram (gm) taken daily for 7 days - 15 subjects | Dietary supplement | Arm 1: Curcumin alone |
| Curcumin conjugated with plant exosomestablets-taken daily for 7 days - 15 subjects | Dietary supplement | Arm 2: Curcumin with plant exosomes |
| No interventionno treatment | Other | Arm 3: no treatment |
Primary outcome
Concentration of curcumin in normal and cancerous tissue
Time frame: 7 days after start of curcumin ingestion
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 secondary outcomes
safety and tolerability of curcumin alone as determined by adverse events
Time frame: 7 days after study enrollment
effects of curcumin on normal and cancerous colon cells by measuring the biomarkers using histochemical staining
Time frame: 7 days after patient enrollment
the immune system response to curcumin, measured by serum cytokine levels
Time frame: 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
Time frame: 7 days after patient enrollment in study
measurement of curcumin alone on metabolic characteristics of normal colon mucosa and colon tumors
Time frame: 7 days after patient enrollment
safety and tolerability of curcumin with plant exosomes as determined by adverse events
Time frame: 7 days after study enrollment
measurement of curcumin mixed with plant exosomes on metabolic characteristics of normal colon mucosa and colon tumors
Time frame: 7 days after patient enrollment on study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Derived from this study: PubMed 29054476Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald W Dryden Jr, MD, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing curcumin and Curcumin conjugated with plant exosomes in people with Colon Cancer, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerald W Dryden Jr, MD, Ph.D (502-852-6991, gerald.dryden@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of curcumin in normal and cancerous tissue (time frame: 7 days after start of curcumin ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01294072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.