What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include 5-aminosalicylic acid (5-ASA) drugs like mesalamine, corticosteroids, immunomodulators, and biologics. 5-ASA drugs can cause side effects such as nausea, headache, and rash. Corticosteroids may lead to weight gain, hypertension, and increased risk of infections. Immunomodulators can cause bone marrow suppression and liver toxicity. Biologics may result in injection site reactions and increased susceptibility to infections. Atorvastatin, while primarily used for cholesterol management, is being studied for its potential in cancer prevention in UC patients; its side effects include muscle pain, liver enzyme abnormalities, and increased risk of diabetes.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Ulcerative Colitis, focusing primarily on anti-inflammatory and immunosuppressive agents. Mesalamine (5-ASA) is commonly used for mild to moderate UC, while corticosteroids like prednisone are used for more severe cases. Immunomodulators such as azathioprine and biologics like infliximab and adalimumab target specific components of the immune system to reduce inflammation. Although atorvastatin is primarily a cholesterol-lowering drug, its potential role in cancer prevention is being explored, similar to how some UC treatments aim to reduce long-term cancer risks associated with chronic inflammation.

What other types of research exist?

Promising novel alternatives to atorvastatin for ulcerative colitis patients include ustekinumab, a monoclonal antibody targeting interleukin-12 and interleukin-23, and vedolizumab, an antibody to the alpha4beta7 integrin. Both have shown efficacy in managing inflammatory bowel disease and may offer additional benefits in cancer prevention.

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Statins

Atorvastatin for Ulcerative Colitis

Q: What is the mechanism of action of this treatment?

The most common treatments for Ulcerative Colitis (UC) include 5-aminosalicylic acid (5-ASA) compounds, corticosteroids, immunomodulators, and biologics. 5-ASA compounds, such as mesalamine, reduce inflammation in the colon by inhibiting the production of inflammatory mediators. Corticosteroids, like prednisone, suppress the immune response to decrease inflammation rapidly. Immunomodulators, such as azathioprine, alter the immune system to prevent chronic inflammation. Biologics, including anti-TNF agents like infliximab, target specific components of the immune system to reduce inflammation. Atorvastatin, primarily used to lower cholesterol, is being studied for its potential role in cancer prevention in UC patients due to its anti-inflammatory properties and ability to induce apoptosis in cancer cells. Understanding these mechanisms is crucial for UC patients as it helps tailor treatment plans to manage symptoms effectively and potentially reduce the risk of complications like colon cancer.

Phase 2

Recruiting

Led By Seema A Khan

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

Participants must have ulcerative colitis with > 8 years history and clinical remission (including the clinical remission for an extraintestinal manifestation/complication) confirmed by yearly surveillance endoscopy examination (Mayo grading < 3)

Must not have

History of chemotherapy within 2 years of screening

Use of corticosteroid therapy in the past 3 months due to high potential of relapse of active disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Summary

This trial studies atorvastatin, a cholesterol-lowering drug, in patients with ulcerative colitis who are at risk of colon cancer. The goal is to see if atorvastatin can reduce cancer risk by lowering cholesterol and affecting certain proteins and genes linked to cancer.

Who is the study for?

Adults aged 18-70 with longstanding ulcerative colitis and a specific P53 mutation, in clinical remission for at least 8 years. They must not have used statins or had chemotherapy within the last year or two respectively, no recent corticosteroid use, and cannot be pregnant. Participants should have stable cholesterol levels and agree to contraception during the study.

What is being tested?

The trial is testing if Atorvastatin can lower colon cancer risk in patients with ulcerative colitis who are at increased risk of large intestinal cancer. It involves taking Atorvastatin versus a placebo while monitoring health through biopsies, blood tests, questionnaires, and biospecimen collection.

What are the potential side effects?

Atorvastatin may cause muscle pain or weakness, liver enzyme changes leading to potential liver damage, digestive issues like nausea or constipation, increased blood sugar levels which could signal diabetes risk, and possible confusion or memory problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am mostly self-sufficient and can carry out daily activities.

Select...

I have had ulcerative colitis for over 8 years and am in remission, confirmed by yearly endoscopy.

Select...

I had hepatitis C but am cured, or I'm being treated with no detectable virus.

Select...

My hepatitis B is under control with treatment.

Select...

My cholesterol is below 240 mg/dl and my LDL-C is under 190 mg/dl.

Select...

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not had chemotherapy in the last 2 years.

Select...

I have used corticosteroids in the last 3 months due to a high risk of my disease returning.

Select...

I have had severe colon issues or colon cancer requiring complete removal of my colon and rectum.

Select...

I have taken statins in the past year.

Select...

I have advanced liver scarring and severe liver problems due to PSC.

Select...

I am an adult as this study is not for children.

Select...

I am not currently taking medications like cyclosporine, certain cholesterol drugs, or strong CYP3A4 inhibitors or inducers.

Select...

I do not have severe widespread or localized ulcerative colitis.

Select...

I do not have HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduction in mutant p53 staining in biopsy samples obtained during colonoscopies done before and after intervention

Secondary study objectives

Analysis of spectrum, hotspot and load of TP53 gene mutations

Banking of colorectal specimens

Clinical efficacy on UC related symptoms

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (atorvastatin, biospecimen collection)Experimental Treatment4 Interventions

Patients receive atorvastatin PO QD for 12 months. Patients also undergo colonoscopy with biopsy, and collection of blood on the trial.

Group II: Arm II (placebo, biospecimen collection)Placebo Group4 Interventions

Patients receive placebo PO QD for 12 months. Patients also undergo colonoscopy with biopsy, and collection of blood on the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Atorvastatin Calcium

2023

Completed Phase 4

~240

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Ulcerative Colitis (UC) include 5-aminosalicylic acid (5-ASA) compounds, corticosteroids, immunomodulators, and biologics. 5-ASA compounds, such as mesalamine, reduce inflammation in the colon by inhibiting the production of inflammatory mediators. Corticosteroids, like prednisone, suppress the immune response to decrease inflammation rapidly. Immunomodulators, such as azathioprine, alter the immune system to prevent chronic inflammation. Biologics, including anti-TNF agents like infliximab, target specific components of the immune system to reduce inflammation. Atorvastatin, primarily used to lower cholesterol, is being studied for its potential role in cancer prevention in UC patients due to its anti-inflammatory properties and ability to induce apoptosis in cancer cells. Understanding these mechanisms is crucial for UC patients as it helps tailor treatment plans to manage symptoms effectively and potentially reduce the risk of complications like colon cancer.