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Polyp prophylactic properties of polyacetylenes from carrots in patients with previous polypectomy--Px7 The study protocol of a multicentre binational randomised controlled trial

Por: Agache · A. · Deding · U. · Kaalby · L. · Kobaek-Larsen · M. · Al-Najami · I. · Ostergaard Hansen · L. · Stryhn · C. · Wilde · D. · Forsberg · A. · Backman · A.-S. · Bates · T. · de Lange · T. · Martling · A. · Baatrup · G.
Introduction

A large bowel cancer chemoprevention potential has been demonstrated by the consumption of carrots, which represent the major dietary source of polyacetylenes. Their interaction with cancer cells and enzyme systems of animals and humans has been systematically investigated over the last 15 years and has now been characterised as anti-inflammatory compounds with antineoplastic effect. Our objective is to investigate whether selected carrot species with a high content of the polyacetylenes falcarinol (FaOH) and falcarindiol (FaDOH) prevent neoplastic transformation and growth in humans, without side effects.

Methods and analysis

We will conduct a multicentre prospective binational (Denmark and Sweden) randomised controlled trial, with the aim to test the clinical effects of adjuvant treatment with carrot juice in patients who had an excision of high-risk colon adenomas. Patients from six centres will be randomised to receive either anti-inflammatory juice made of carrots high in FaOH and FaDOH or placebo. We will compare the proportion of participants with recurrent adenoma and mean size of them, found in the 1-year follow-up colonoscopy between the two randomised groups.

Ethics and dissemination

Informed written consent will be obtained from all participants before randomisation. The study was approved by the regional ethics committee in Denmark (ref. S-20230072) and Sweden (ref. 2024-04732-01). After completion of the trial, we plan to publish two articles in high-impact journals: one article on primary and secondary outcomes, respectively.

Trial registration number

NCT06335420.

Mesalamine for Colorectal Cancer Prevention Programme in Lynch syndrome (MesaCAPP): a multicentre, multinational, randomised, two-arm, double-blind, phase II clinical study with mesalamine or placebo in carriers with Lynch syndrome - a study protocol

Por: Backman · A.-S. · Frank · A. · Lindberg · L. J. · Ljungman · D. · Silander · G. · Gustafsson · R. J. · Bozso · T. · Schmidt · P. T. · Ingre · M. · Mittlbock · M. · Löwbeer · C. · Marsal · J. · Lindblom · A. · Tham · E. · Therkildsen · C. · Gasche · C. · The International MesaCAPP Stu
Introduction

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.

Methods and analysis

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 (

Ethics and dissemination

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.

Trial registration number

ClinicalTrials.gov: NCT04920149. EudraCT: 2019-003011-55. EU CT: 2024-514765-19-01.

Framing Person‐Centred Leadership in Residential Care: A Cross‐Cultural Adaptation of the Aged‐Care Clinical Leadership Qualities Framework

ABSTRACT

Aim

To cross-culturally adapt a framework for person-centred leadership in residential care for older people in Sweden.

Design

This study has an exploratory and descriptive design.

Methods

The translation procedure followed a cyclic process of translation into Swedish and back-translation into English by two independent bilingual linguists. An evaluation of conceptual and semantic equivalence and comprehensiveness between the original English version and the translated Swedish version was performed by an expert committee. The translated version of the framework was validated by leaders (n = 34) in residential care, who assessed its relevance through a web form. The adaptation of the framework followed recommended guidelines for cross-cultural adaptation.

Results

The translation procedure resulted in two minor changes related to the wording in two descriptors. The results of the validation procedure showed that the framework is relevant for leaders in Swedish residential care for older people.

Conclusion

The cross-culturally adapted framework is useful and suitable for leaders in Swedish residential care for older people. The framework clarifies the leader's role and identifies leadership attributes and requirements for person-centred leadership in residential care, thereby providing support to leaders by framing person-centred leadership.

Implications for the Profession and/or Patient Care

The framework can be used as a guide for leadership training and/or development initiatives in residential care. It can be further extended to nursing curriculums, leadership development programs, and organisational performance and development processes. It may also provide a foundation for policy and guidelines by establishing the activities required for leaders to promote person-centredness in the care of older people.

Reporting Method

This study followed the STROBE checklist for cross-sectional studies.

Patient and Public Contribution

There was no patient or public contribution.

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