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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days after study enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after study enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Concentration of curcumin in normal and cancerous tissue
Secondary outcome measures
effects of curcumin on normal and cancerous colon cells by measuring the biomarkers using histochemical staining
immune response in ex vivo cell cultures of colon cancer cells treated with curcumin and Exo-cur, to be evaluated by using histochemical staining
measurement of curcumin alone on metabolic characteristics of normal colon mucosa and colon tumors
+4 moreSide effects data
From 2018 Phase 2 trial • 35 Patients • NCT0210042340%
Fatigue
37%
Diarrhea
34%
Hyperglycemia
26%
Platelet count decreased
20%
Anemia
20%
Lymphocyte count increased
17%
Alkaline phosphatase increased
14%
Hypertension
14%
Cough
14%
Nausea
14%
Lymphocyte count decreased
11%
Stool color change
11%
Alanine aminotransferase increased
11%
Creatinine increased
11%
Hypercalcemia
9%
Anxiety
9%
Insomnia
9%
Hyponatremia
9%
Pain
9%
Aspartate aminotransferase increased
9%
Sore throat
6%
Dyspnea
6%
Urinary tract infection
6%
Abdominal pain
6%
Fever
6%
Flu like symptoms
6%
Neutrophil count decreased
6%
Weight gain
6%
Hypocalcemia
6%
Allergic rhinitis
6%
Chills
6%
Pain in extremity
6%
Nasal congestion
6%
Generalized muscle weakness
3%
Hearing Impaired
3%
Hypothyroidism
3%
Bloating
3%
White blood cell decreased
3%
Flu like symptoms, body aches
3%
Sinus pain
3%
Edema limbs
3%
Hyperkalemia
3%
Dyspepsia
3%
Malaise
3%
Bone pain
3%
Sinusitis
3%
Chronic kidney disease
3%
Chest congestion
3%
Intermittent night sweats
3%
Blurred vision
3%
Anorexia
3%
Infection under chin
3%
Lymph gland infection
3%
Skin infection
3%
Bruising
3%
White blood cell count increased
3%
Weight loss
3%
Hot flashes
3%
Hypernatremia
3%
Hyperuricemia
3%
Hypokalemia
3%
Joint range of motion decreased
3%
Night sweats
3%
Dysesthesia
3%
Headache
3%
Dysuria
3%
Brittle nails
3%
Stomach cramps
3%
Depression
3%
Productive cough
3%
Blood bilirubin increased
3%
Skin integrity
3%
Rectal pain
3%
Nail infection
3%
Dehydration
3%
Papulopustular rash
3%
Tooth infection
3%
Upper respiratory infection
3%
low vitamin D level
3%
Dizziness
3%
Hematuria
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
~1120
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,949 Total Patients Enrolled
Gerald W Dryden Jr, MD, PhDPrincipal InvestigatorUniversity of Louisville
Frequently Asked Questions
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