Your session is about to expire
← Back to Search
Other
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
No Placebo-Only Group
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 belowSelect...
I have been officially diagnosed with colon cancer.
Select...
I have never been diagnosed with diabetes.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am older than 20 years.
Select...
Surgery to remove my cancer is possible.
Select...
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
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 • NCT0210042340%
Fatigue
37%
Diarrhea
34%
Hyperglycemia
26%
Platelet count decreased
20%
Anemia
20%
Lymphocyte count increased
17%
Alkaline phosphatase increased
14%
Nausea
14%
Cough
14%
Hypertension
14%
Lymphocyte count decreased
11%
Stool color change
11%
Hypercalcemia
11%
Alanine aminotransferase increased
11%
Creatinine increased
9%
Insomnia
9%
Aspartate aminotransferase increased
9%
Pain
9%
Sore throat
9%
Hyponatremia
9%
Anxiety
6%
Nasal congestion
6%
Flu like symptoms
6%
Allergic rhinitis
6%
Dyspnea
6%
Urinary tract infection
6%
Weight gain
6%
Abdominal pain
6%
Fever
6%
Chills
6%
Neutrophil count decreased
6%
Hypocalcemia
6%
Generalized muscle weakness
6%
Pain in extremity
3%
White blood cell decreased
3%
Lymph gland infection
3%
Stomach cramps
3%
Blood bilirubin increased
3%
Depression
3%
Upper respiratory infection
3%
Chest congestion
3%
Hypothyroidism
3%
Nail infection
3%
Malaise
3%
Bruising
3%
Skin infection
3%
Edema limbs
3%
Tooth infection
3%
Intermittent night sweats
3%
Dehydration
3%
Night sweats
3%
Infection under chin
3%
Blurred vision
3%
Weight loss
3%
Anorexia
3%
Brittle nails
3%
Sinusitis
3%
Bloating
3%
Rectal pain
3%
Productive cough
3%
Hyperkalemia
3%
Papulopustular rash
3%
Skin integrity
3%
Dysuria
3%
Hypernatremia
3%
Hearing Impaired
3%
White blood cell count increased
3%
Chronic kidney disease
3%
Hot flashes
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)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
348 Previous Clinical Trials
77,666 Total Patients Enrolled
Gerald W Dryden Jr, MD, PhDPrincipal InvestigatorUniversity of Louisville