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Plant Exosome-Delivered Curcumin for Colon Cancer

N/A
Recruiting
Led By Gerald W Dryden Jr, MD, PhD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have definitive diagnosis of colon cancer.
No history of diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days after start of curcumin ingestion
Awards & highlights

Summary

This trial will investigate whether plant exosomes can deliver curcumin more effectively to normal colon tissue and colon tumors.

Who is the study for?
This trial is for adults over 20 with colon cancer who can potentially have surgery to remove their tumor. They should be relatively healthy, able to perform daily activities (ECOG status 0-2), and not have diabetes or life-limiting conditions. Participants need normal blood cell counts and must understand the study's experimental nature, agreeing to it by signing a consent form.
What is being tested?
The study is testing if plant exosomes can better deliver curcumin—a compound from turmeric—to colon tissue and tumors. It compares the effects of regular curcumin intake with curcumin attached to plant exosomes against no treatment at all, aiming to overcome previous issues of low absorption in similar treatments.
What are the potential side effects?
While specific side effects are not listed here, typical reactions may include digestive discomfort due to curcumin itself or potential immune responses triggered by foreign substances like plant exosomes introduced into the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been officially diagnosed with colon cancer.
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I have never been diagnosed with diabetes.
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I can take care of myself but might not be able to do heavy physical work.
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I am older than 20 years.
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Surgery to remove my cancer is possible.
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My blood tests show enough white blood cells and platelets.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after study enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after study enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Concentration of curcumin in normal and cancerous tissue
Secondary study objectives
Curcumin
safety and tolerability of curcumin with plant exosomes as determined by adverse events

Side effects data

From 2018 Phase 2 trial • 35 Patients • NCT02100423
40%
Fatigue
37%
Diarrhea
34%
Hyperglycemia
26%
Platelet count decreased
20%
Anemia
20%
Lymphocyte count increased
17%
Alkaline phosphatase increased
14%
Hypertension
14%
Nausea
14%
Cough
14%
Lymphocyte count decreased
11%
Stool color change
11%
Creatinine increased
11%
Hypercalcemia
11%
Alanine aminotransferase increased
9%
Insomnia
9%
Pain
9%
Aspartate aminotransferase increased
9%
Sore throat
9%
Hyponatremia
9%
Anxiety
6%
Urinary tract infection
6%
Weight gain
6%
Nasal congestion
6%
Chills
6%
Dyspnea
6%
Neutrophil count decreased
6%
Allergic rhinitis
6%
Abdominal pain
6%
Fever
6%
Flu like symptoms
6%
Hypocalcemia
6%
Generalized muscle weakness
6%
Pain in extremity
3%
Hearing Impaired
3%
Stomach cramps
3%
Dysuria
3%
Nail infection
3%
Malaise
3%
Upper respiratory infection
3%
Blood bilirubin increased
3%
Papulopustular rash
3%
Intermittent night sweats
3%
Productive cough
3%
Hypothyroidism
3%
Skin infection
3%
Hyperkalemia
3%
Edema limbs
3%
Tooth infection
3%
Bruising
3%
White blood cell decreased
3%
Dehydration
3%
Chest congestion
3%
Night sweats
3%
Weight loss
3%
Depression
3%
Skin integrity
3%
Anorexia
3%
Brittle nails
3%
Sinusitis
3%
Bloating
3%
Rectal pain
3%
Blurred vision
3%
Hypernatremia
3%
Infection under chin
3%
White blood cell count increased
3%
Chronic kidney disease
3%
Hot flashes
3%
Lymph gland infection
3%
Dyspepsia
3%
Hematuria
3%
Hyperuricemia
3%
Hypokalemia
3%
low vitamin D level
3%
Bone pain
3%
Joint range of motion decreased
3%
Dizziness
3%
Dysesthesia
3%
Headache
3%
Flu like symptoms, body aches
3%
Sinus pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Curcumin, Cholecalciferol)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm 3: no treatmentExperimental Treatment1 Intervention
subjects will not take curcumin or plant exosomes
Group II: Arm 2: Curcumin with plant exosomesExperimental Treatment1 Intervention
Subjects take curcumin conjugated with plant exosomes.
Group III: Arm 1: Curcumin aloneExperimental Treatment1 Intervention
Subjects take curcumin orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
curcumin
2017
Completed Phase 4
~1180

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
342 Previous Clinical Trials
77,298 Total Patients Enrolled
Gerald W Dryden Jr, MD, PhDPrincipal InvestigatorUniversity of Louisville
~0 spots leftby Nov 2024
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