What Studies are Enrolling Right Now?

This phase II trial is studying how well acolbifene works in preventing cancer in premenopausal women at high risk of breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of acolbifene may stop cancer from growing or coming back. The principal investigator for the trial is Carol Fabian, MD, at University of Kansas Medical Center. 

See more details about the trial at Study Details | NCT00853996 | Acolbifene in Preventing Cancer in Premenopausal Women at High Risk of Breast Cancer | ClinicalTrials.gov 

Study sites that are open (or opening soon) and contacts at each site are as follows:

• University of Kansas, Kansas City, KS: Amy Kreutzjans akreutzjans@kumc.edu

• Northwestern University, Chicago IL: Sarah DeHorn sarah.dehorn@northwestern.edu

• Ohio State University, Columbus OH: Cevasco, Karly karly.cevasco@osumc.edu

• City of Hope, Duarte CA: Cynthia Basulto cbasulto@coh.org

This phase II trial evaluates low dose tamoxifen, with or without omega-3 fatty acids, for reducing risk of breast cancer among postmenopausal women who have a BMI greater than 25 kg/m2 and have at least one risk factor for developing breast cancer. Low dose tamoxifen with or without omega-3 fatty acids may be effective at reducing risk of breast cancer among women who are postmenopausal and at increased risk.  The principal investigator for the trial is Lauren Nye, MD, at University of Kansas Medical Center. 

See more details about the trial at Study Details | NCT06195306 | Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction | ClinicalTrials.gov 

Study sites that are open (or opening soon) and contacts at each site are as follows:

• University of Kansas, Kansas City, KS: Amy Kreutzjans akreutzjans@kumc.edu

• Ohio State University, Columbus OH: Cevasco, Karly karly.cevasco@osumc.edu

This phase 1a/b trial studies exercise therapy for prevention of colon cancer in People who have FAP. The exercise therapy is comprised of moderate walking on a treadmill, and it is supervised remotely by an exercise physiologist. A treadmill is provided for study participants to use in their own home. The primary objective of the study is to identify the most appropriate level of exercise therapy to be used for subsequent investigation in larger trials. This trial is administered by ClinCaP. Drs. Samara Rifkin (University of Michigan) Carol Burke (Cleveland Clinic) and Lee Jones (City of Hope) are the trial PIs. 

See more details about the trial at:

https://clinicaltrials.gov/study/NCT06641310?cond=Colorectal%20Neoplasms&term=rifkin&intr=exercise&rank=1 

The recruiting sites are:

Cleveland Clinic Foundation, Cleveland OH; Dr. Carol Burke

University of Michigan, Ann Arbor; Dr. Samara Rifkin

This phase II trial evaluates response-guided low-dose tamoxifen for reducing breast density in women who are at higher than average risk for breast cancer. Increased breast density is a well established risk factor for breast cancer. Tamoxifen works by blocking the effects of the hormone estrogen in the breast. Tamoxifen has been shown to reduce breast density, even at low dosages, and is approved for the prevention of breast cancer. This protocol PI for this inter-consortium trial is Seema Khan, M.D., at Northwestern University. ClinCaP administers the trial at University of Michigan as an accruing site.

See more details about the trial at:

https://clinicaltrials.gov/study/NCT06184750?cond=Breast%20Cancer&intr=tamoxifen&term=khan&rank=7

The recruiting site for ClinCaP is:

University of Michigan, Ann Arbor; Dr. Melissa Pilewski

This phase I trial tests the safety, side effects, and best dose of ONC201 in preventing colorectal cancer in patients with familial adenomatous polyposis (FAP) or a history of multiple polyps. ONC201 may stop the growth of tumor cells by blocking key enzymes needed for polyp growth. The study principal investigator is Alexander Raufi, MD, at Rhode Island Hospital.

See more details about the trial at:

https://clinicaltrials.gov/study/NCT05630794?term=raufi&intr=ONC201&rank=1 

The recruiting sites are:

Cleveland Clinic Foundation, Cleveland OH; Dr. Carol Burke

Ohio State University, Columbus, OH; Dr. Peter Stanich

Rhode Island Hospital, Providence, CT; Dr. Alexander Raufi and Dr. Samir Shah

University of Michigan, Ann Arbor, MI; Dr. Elena Stoffel

This phase II trial studies the effect of obeticholic acid in treating patients with Barrett's esophagus. Obeticholic acid has shown anti-cholestatic, anti-inflammatory and anti-fibrotic effects mediated by FXR activation. It down regulates bile acid availability and decreases proinflammatory cytokine production including IL-1beta and TNFalpha in human enterocytes and immune cells. This chain of events reduces the bile acid exposure in esophagus tissue thereby limiting bile acid induced damage and dysplastic progression. The principal investigator is Prashanthi Thota, MD at Cleveland Clinic.

See more details about the trial at  https://clinicaltrials.gov/study/NCT04939051?term=%22thota%22&intr=Obeticholic%20Acid&rank=1#study-overview

The open study sites are:

Cleveland Clinic Foundation, Cleveland OH; Dr. Prashanthi Thota

Case Western Reserve University, Cleveland, OH; Dr. Amitabh Chak

University of Kansas, Kansas City KS; Dr. Ajay Bansal

University of North Carolina, Chapel Hill, NC; Dr. Nicholas Shaheen