Cholesterol drug shows promise in preventing colon cancer for colitis patients
NCT ID NCT04767984
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether atorvastatin, a widely used cholesterol medication, can reduce the risk of colon cancer in people with long-standing ulcerative colitis who carry a specific genetic mutation (P53). About 42 participants will take either atorvastatin or a placebo for a period, and researchers will measure changes in colon tissue samples to see if the drug lowers cancer-related markers. The goal is to find a safe, affordable way to prevent cancer in this high-risk group.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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42 people
The number who actually took part.
- Started
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Sep 2021
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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) * They must be stable on maintenance therapy with mesalamine, thiopurines or biologics for over 3 months (Ulcerative Colitis Disease Activity Index \[UCDAI\] =\< 1) * A history of segmental colon resection is allowed * UC in clinical remission, but with dysplasia-associated lesion or mass (DALM) at entry endoscope examination and DALM was completely resected by endoscopic mucosa resection, is allowed * Participants 18-70 years old (both men and women). This is the standard age range for routine ulcerative colitis surveillance in adults * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * White blood cell count within normal institutional limits or absolute neutrophil count \>= 1,500/uL * Platelets \>= 100,000/uL * Total bilirubin within normal institutional limits, unless known to have Gilberts syndrome * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (SGPT) =\< 1.5 X institutional upper limit of normal (ULN) * Creatinine =\< 1.5 X institutional ULN * Plasma level of cholesterol \< 240 mg/dl or LDL-C \< 190 mg/dl (since cholesterol \> 240 mg/dl and LDL-C \> 190 mg/dl need high dose (40 - 80 mg) atorvastatin per day to control hypercholesterolemia) * For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Participants on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible * Atorvastatin is contraindicated in pregnancy since it affects cholesterol synthesis pathway. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of baseline pregnancy test, throughout the duration of the study, and for 1 month following cessation of study drug. Females must begin adequate contraception immediately following screening pregnancy test. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. If she is pregnant, she will be immediately withdrawn from the study and followed until the birth of the child * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Ulcerative proctitis (since patients with ulcerative proctitis have a significantly lower risk of developing colorectal cancer \[CRC\] than those with pancolitis or localized UC in left colon) * Participants with medical conditions that, in the opinion of the investigator, would preclude the treatment intervention and colonoscopy, or limit ability to comply with therapy * Participants with pancolitis or localized UC with total Mayo score \>= 3 including Mayo endoscopic sub-score \< 3 are excluded * Use of corticosteroid therapy in the past 3 months due to high potential of relapse of active disease * Use of statins in the last 12 months * Use of any investigational drugs within the past 3 months * A history of high-grade dysplasia or CRC or pan/severe colitis with total proctocolectomy * History of chemotherapy within 2 years of screening * History of allergic reactions attributed to atorvastatin * Concomitant primary sclerosing cholangitis (PSC) with stage 4 liver fibrosis (biliary cirrhosis) and severe liver functional alteration * Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or breastfeeding participants are excluded * Human immunodeficiency virus (HIV)-positive participants are excluded due to anti-retroviral therapy that affect atorvastatin effect * Children are excluded from this study since disease duration is usually \< 8 years and there is no data about p53 mutation in this patient population * Current use of cyclosporine, fibrates (e.g., gemfibrozil, fenofibrate), strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, human immunodeficiency virus (HIV) protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, or cobicistat-containing products), or strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's wort, bosentan, efavirenz, etravirine, modafinil, nafcillin)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Northwestern University
Chicago, Illinois, 60611, United States
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University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
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University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
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