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Lynch syndrome (LS) carriers have a 20–46% lifetime risk of colorectal cancer (CRC) due to mismatch repair gene variants. Mesalamine (5-ASA, 5-aminosalicylic acid), used safely in patients with ulcerative colitis, may reduce CRC risk in LS by decreasing microsatellite instability, a key driver of LS-related cancer. This study evaluates 5-ASA’s efficacy as a tolerable chemopreventive drug, aiming to improve long-term CRC prevention in LS.
This multicentre, multinational, randomised, double-blind, two-arm, phase II clinical study will compare the effects of a 2-year daily intake of 5-ASA (2000 mg) to placebo in LS carriers. The primary objective is to assess whether mesalamine reduces colorectal neoplasia, both benign and malignant, compared with placebo in LS carriers, as detected by colonoscopy at the end of the treatment period (24 months±1 month) and on study completion. Secondary objectives include evaluating whether 5-ASA reduces neoplasia/tumour multiplicity and progression compared with placebo at specified time points, examining variations in the effects of 5-ASA versus placebo based on cancer history, sex and age (
The trial is currently open for enrolment, having received ethical approval from the Regional Ethical Review Board in Stockholm and funding from the Swedish Research Council. The study protocol is the finalised V.10.0 (11 April 2024), transitioned to the European Clinical Trials Information System. LS remains underdiagnosed, which may limit recruitment. The results are of global interest and will be published in peer-reviewed journals and presented at scientific conferences.
ClinicalTrials.gov: NCT04920149. EudraCT: 2019-003011-55. EU CT: 2024-514765-19-01.
To explain and understand leading care close to older persons in community home care from the perspective of registered nurses (RNs).
Leading care close to older persons in home care is an overlooked and not well-described phenomenon. In home care, specific demands are placed on the registered nurse, as responsible for leading care guided by the older person's expectations and desires.
A reflective lifeworld hermeneutic approach grounded in the philosophy of phenomenology and hermeneutics. The study followed the COREQ checklist.
Individual interviews were conducted with nine RNs working in community home care in a community in western Sweden. The data were analysed with a lifeworld hermeneutic approach.
The findings present four partially interpreted themes: leading with respect in a shared space, leadership that involves existential questions of life, balancing responsibility enables preservation of autonomy and challenges in maintaining a patient perspective. The partially interpreted themes conclude in a main interpretation: The patient perspective as an anchor when balancing responsibility for another person in an existential vulnerability of life.
Leading care means being both close to the patient and at a distance when caring is performed through the hands of others. Ethical demands are placed on RNs as they encounter the vulnerability of the older person.
The findings can contribute to a greater understanding of the meaning of RNs as leaders and may have an impact for decision makers and policies to create conditions for leadership that contributes to dignified care for older persons in community home care.
Registered nurses working in community home care participated in data collection.
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