Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
NCT ID: NCT04920149
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2022-03-21
2045-09-30
Brief Summary
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Detailed Description
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The aim of the study is to investigate the effect of regular treatment with mesalamine (5-ASA) on the occurrence of any colorectal neoplasia, tumor multiplicity (the number of detected adenomas/carcinomas) and tumor progression in LS patients.
Tumor multiplicity and tumor progression (severity of the neoplastic lesions) will be investigated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Mesalamine
Mesalamine (Mesalazine, Pentasa sachet, 5-ASA) 2 g once daily for 2 years.
Mesalamine
The IMP will be supplied as sachets with slow-releasing granules.
Placebo
Placebo for Mesalamine (Mesalazine, Pentasa sachet, 5-ASA) 2 g once daily for 2 years.
Placebo
The IMP will be supplied as sachets with slow-releasing granules.
Interventions
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Mesalamine
The IMP will be supplied as sachets with slow-releasing granules.
Placebo
The IMP will be supplied as sachets with slow-releasing granules.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female subjects with the age of 30 years or older
* Females who have been post-menopausal more than one (1) year or females of childbearing potential using a highly efficient method of contraception with less than 1% failure rate (i.e. oral hormonal contraceptives, hormone implants, hormone injections, sterilization, hormonal or copper intrauterine device, sterilized/vasectomized partner, or diaphragm in combination with a condom, spermicide or birth control pills) or should agree to abstain from heterosexual activity during treatment period. Females of childbearing potential must have a negative pregnancy test at screening and before randomization.
* Signed written informed consent prior to inclusion in the study
Exclusion Criteria
* Carriers of germline mutations in PMS2
* Patients with history of stage 3 and 4 CRC are excluded
* Presence of metastatic disease
* Regular use of aspirin/ASA: daily use of ≥100mg in more than 3 continuous months within the last year
* Regular use of NSAIDs or COX-2 inhibitors: daily use in more than 3 continuous months within the last year
* Hypersensitivity to 5-ASA
* Patients after any subtotal or total colectomy
* Colorectal surgery within the previous 6 months
* Unwillingness to participate or who is considered incompetent to give an informed consent
* Pregnant or breastfeeding women
* Participation in another clinical study investigating another IMP within 1 month prior to screening
* Renal insufficiency (GFR \<30ml/min/1.73m2)
* Severe liver disease or liver failure (elevation of liver enzymes above 3xULN)
* Current or history of serious psychiatric disorder or alcohol/drug abuse that in the opinion of the investigator may impact the assessment of IMP safety and efficacy or protocol adherence
* Prior history of myocarditis or pericarditis. Other severe acute or chronic medical condition such as severe chronic lung (COPD, including asthma, kidney and heart diseases) or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or ability to comply with study procedures, investigational product administration and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
30 Years
ALL
No
Sponsors
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The Swedish Research Council
OTHER_GOV
Karolinska Institutet
OTHER
Ann-Sofie Backman
OTHER
Responsible Party
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Ann-Sofie Backman
Consultant gastroenterology
Principal Investigators
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Ann-Sofie Backman, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Hvidovre Hospital
Hvidovre, , Denmark
Sahlgrenska University Hsospital
Gothenburg, Gothenburg, Sweden
Skåne University Hospital
Malmo, Skåne County, Sweden
Ersta Hospital/Ersta Diakoni
Stockholm, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Norrland University Hospital
Umeå, , Sweden
Akademiska hospital
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Ole Thorlacius-Ussing, MD PhD
Role: primary
Lars Joachim Lindberg, MD PhD
Role: primary
David Ljungman, MD PhD
Role: primary
Rita J Gustafsson, MD PhD
Role: primary
Ann-Sofie Backman, MD PhD
Role: primary
Gustav Silander, MD PhD
Role: primary
Peter Thelin Schmidt, MD PhD
Role: primary
Other Identifiers
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MesaCAPP
Identifier Type: -
Identifier Source: org_study_id