Risk Reduction Clinical Trial
Official title:
Randomized Window of Opportunity Trial of Anthocyanin Extract and Phospholipid Curcumin in Subjects With Colorectal Adenoma
Colonic adenomatous polyps are pre cancer lesions and are used as intermediate markers for
testing agents with potential cancer prevention.
Meriva© is a bioavailable form of curcumin, a polyphenolic compound obtained from turmeric
(Curcuma longa L.) endowed with anti-inflammatory, antioxidant and antitumor effects. In vivo
data indicate that curcumin formulated with phosphatidylcholine furnishes higher blood levels
of parent agent than natural curcumin.
Mirtoselect©, an anthocyanin mixture from bilberry containing isolated cyanidin-3-glucoside
(C3G), the most abundant anthocyanin in diet, prevents intestinal adenoma formation in the
Apc(Min) mouse model.
The investigators hypothesize that the combination of both agents will decrease the
expression of proteins involved in colon tumorigenesis relative to placebo.
The change of biomarker expression between pre-treatment biopsy and post-treatment endoscopic
resection in the target adenoma and the normal rectal mucosa will be the response measures.
The primary response measure is the change of immunohistochemical (IHC) expression of
β-catenin in adenomatous tissue and normal rectal mucosa. Secondary response measures are the
changes of IHC Nuclear Factor-Kβ (NFKβ), cell proliferation by Ki-67 Labeling Index and
apoptosis by P53 in adenomatous and adjacent normal mucosa.
The study design is a phase II, randomized, double blind, placebo controlled, window of
opportunity trial of the combination of Mirtoselect 1 gr/day+Meriva 1 gr/day or placebo.
Subjects with histological confirmation of colorectal adenomatous polyps >1 cm not suitable
to immediate complete removal will be enrolled in a 4-week intervention trial before
endoscopic polypectomy.
The demonstration of a biological activity of the two agent combination may provide the
rationale for a phase III trial aimed at reducing the risk of colon cancer in high risk
subjects.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05009251 -
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
|
N/A | |
| Completed |
NCT05509270 -
Efficacy of Communication Modalities for Promoting Flu Shots
|
N/A | |
| Completed |
NCT05343208 -
Effectiveness of Online Therapy to Prevent Burnout
|
N/A | |
| Completed |
NCT03833713 -
Utilizing Text Messaging to Improve Vehicle Safety Among At-Risk Young Adults
|
N/A | |
| Recruiting |
NCT06001892 -
Tennessee Youth Prepared for Success
|
N/A | |
| Completed |
NCT04323137 -
Encouraging Flu Vaccination Among High-Risk Patients Identified by ML
|
N/A | |
| Recruiting |
NCT03109899 -
Personalized HIV and STI Testing Tool
|
N/A | |
| Recruiting |
NCT05017948 -
Alleviating Geriatric Inpatients' Medication-related Iatrogenesis
|
N/A | |
| Completed |
NCT05509283 -
Nudging Flu Vaccination in Patients at Moderately High Risk for Flu and Flu-related Complications
|
N/A | |
| Recruiting |
NCT05353283 -
PrEP Point-of-Care Brief-Intervention for Adherence Among Young Men Who Have Sex With Men
|
N/A | |
| Recruiting |
NCT04294381 -
Achievement and Adherence to Behavioral Health Goals in the Setting of Patient-Directed Goal Choice
|
N/A | |
| Recruiting |
NCT04500977 -
Training Health Promotion Women Community Leaders
|
N/A | |
| Recruiting |
NCT03319927 -
Reducing Pesticide Exposures in Child Care Centers
|
N/A | |
| Completed |
NCT03981952 -
Salmonella Conjugates CVD 1000: Study of Responses to Vaccination With Trivalent Invasive Salmonella Disease Vaccine
|
Phase 1 | |
| Completed |
NCT03177512 -
LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing PrEP for Young Men Who Have Sex With Men
|
N/A | |
| Recruiting |
NCT04374747 -
Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk
|
N/A | |
| Recruiting |
NCT06020469 -
Comparative Effects of Ciprofol and Propofol on Pain Intensity on the First Day After Surgery: a Retrospective, Propensity Score Matched, Cohort Study
|
||
| Recruiting |
NCT05569460 -
Construction of Perioperative Medical Data Platform and Its Typical Practice to Predict Postoperative Acute Moderate to Severe Pain With Machine Learning Models
|
||
| Not yet recruiting |
NCT03222960 -
Improving Caries Risk Using Propolis-containing Versus Fluoride-containing Toothpastes in High Caries Risk Patients
|
N/A | |
| Completed |
NCT03965221 -
Comparison of Men's Prevention Apps to Research Efficacy
|
N/A |