Periodic Reporting for period 1 - POET-mCRC (Exercise training in metastatic colorectal cancer patients – effects on tumor recurrence, physiological adaptations and disease progression.)
Periodo di rendicontazione: 2022-03-01 al 2025-02-28
Colorectal cancer (CRC) is the third most common cancer worldwide and the second most common cancer in Europe. Approximately 25% of patients present with liver metastases at the time of primary diagnosis, the most frequent site of metastasis, while a further ~30% develop hepatic metastases during the disease course. Surgical treatment of liver metastases has become a mainstay in the CRC treatment and has significantly improved disease-free status and overall survival. Despite these advances, 50-75% of patients experience a relapse in less than two years following metastatic tumor removal. Repeated rounds of surgery and systemic therapy impose substantial physiological burden and are associated with deterioration in functional capacity and health-related quality of life. Thus, patients with metastatic CRC (mCRC) comprise a unique, and large, patient cohort characterized by high risk of tumor recurrence and progressive physical deconditioning, who will benefit from in-depth exploration of adjunct treatment strategies with direct implications for cancer specific outcomes.
The POET-mCRC study is designed to investigate the effects of a 24-week combined aerobic and resistance exercise intervention, delivered at two predefined training doses, on key clinical and physiological outcomes in patients with mCRC; namely physical fitness, quality of life, tumor recurrence and chemotherapy dose intensity, metabolism and immune function.
The POET-mCRC study is designed to investigate the effects of a 24-week combined aerobic and resistance exercise intervention, delivered at two predefined training doses, on key clinical and physiological outcomes in patients with mCRC; namely physical fitness, quality of life, tumor recurrence and chemotherapy dose intensity, metabolism and immune function.
In the initial phase, I developed the study protocol and all patient-related materials in accordance with local Ethics Committee requirements and obtained Ethics Approval, as well as all additional required approvals from the relevant managerial and scientific bodies (e.g. local Personal Data Protection Office). Furthermore, I established project-specific electronic case report forms within an anonymized database and recruited and trained clinical exercise physiologists to support study visits and supervise the exercise sessions.
In the execution phase, patients with colorectal cancer and liver metastases were enrolled and randomized to high-dose exercise, moderate-dose exercise, or usual care. I oversaw all aspects of trial conduct, including coordination of study visits, delivery of supervised training sessions, management of study personnel, procurement of equipment, and data management.
I disseminated the study aims and design at international scientific meetings, including the European College of Sport Science (2022), the Marie Curie Alumni Association International Conference (2024), and the Moving Beyond Conference (2025). Throughout the Fellowship period, I contributed to academic teaching, delivering courses on exercise and cancer within the PhD course Exercise as Medicine at the University of Copenhagen, Denmark and the Master’s course Lifestyle Medicine at the University of Thessaly, Greece. In parallel, I pursued professional development through targeted courses and networking/leadership activities, including participation in the Danish Diabetes and Endocrine Academy Postdoc Summit (2023), selection as a finalist in the MSCA Science–Policy Pitch Competition (2023), and attendance at the MSCA Presidency Conference (2025). Notably, I was also selected for the two-year Exercise is Medicine European Emerging Leader Program which I completed in fall 2025, supporting the integration of exercise as adjunct treatment into healthcare systems.
The POET-mCRC project is currently ongoing, and no outcome results are available at this time. All enrolled participants have completed the 24-week exercise intervention, however, 9- and 12-month follow-up assessments remain outstanding for 19 participants. The last patient last visit (LPLV) is expected to be completed in the summer of 2026 after which data will be cleaned, locked, and analyzed, and results subsequently disseminated. Baseline data of all included participants are available; however, in compliance with ICH-GCP guidelines and because the Statistical Analysis Plan is still being finalized, we will refrain from presenting any data prior to database lock (after LPLV).
In the execution phase, patients with colorectal cancer and liver metastases were enrolled and randomized to high-dose exercise, moderate-dose exercise, or usual care. I oversaw all aspects of trial conduct, including coordination of study visits, delivery of supervised training sessions, management of study personnel, procurement of equipment, and data management.
I disseminated the study aims and design at international scientific meetings, including the European College of Sport Science (2022), the Marie Curie Alumni Association International Conference (2024), and the Moving Beyond Conference (2025). Throughout the Fellowship period, I contributed to academic teaching, delivering courses on exercise and cancer within the PhD course Exercise as Medicine at the University of Copenhagen, Denmark and the Master’s course Lifestyle Medicine at the University of Thessaly, Greece. In parallel, I pursued professional development through targeted courses and networking/leadership activities, including participation in the Danish Diabetes and Endocrine Academy Postdoc Summit (2023), selection as a finalist in the MSCA Science–Policy Pitch Competition (2023), and attendance at the MSCA Presidency Conference (2025). Notably, I was also selected for the two-year Exercise is Medicine European Emerging Leader Program which I completed in fall 2025, supporting the integration of exercise as adjunct treatment into healthcare systems.
The POET-mCRC project is currently ongoing, and no outcome results are available at this time. All enrolled participants have completed the 24-week exercise intervention, however, 9- and 12-month follow-up assessments remain outstanding for 19 participants. The last patient last visit (LPLV) is expected to be completed in the summer of 2026 after which data will be cleaned, locked, and analyzed, and results subsequently disseminated. Baseline data of all included participants are available; however, in compliance with ICH-GCP guidelines and because the Statistical Analysis Plan is still being finalized, we will refrain from presenting any data prior to database lock (after LPLV).
The POET-mCRC project incorporates several innovative components. The dose-response approach will enable the identification of potential differences between the prescribed exercise doses, determine whether one is superior to the other, and possibly establish the minimum effective dose required for triggering health benefits in patients with metastatic colorectal cancer.
Importantly, the project focuses on a largely overlooked patient population - individuals with advanced-stage colorectal cancer and liver metastases - providing valuable insights into this specific, vulnerable patient group. The output of this project will generate evidence to inform the further development of tailored exercise prescription in patients with metastatic colorectal cancer, an area in which robust, dose-specific guidance is currently lacking.
A key innovation of the project is the decentralized delivery of the exercise intervention. Facilitation of supervised exercise sessions via online platforms enhances accessibility for patients living in remote locations, in geographical areas outside main cities, who would otherwise be unable to participate due to travel constrains.
Moreover, since geographical location is often associated with socioeconomical and educational disparities, expanding access across wider regions helps promote equity among patients with cancer.
Collectively, the dose-response framework, the specific patient population, and the decentralized delivery approach represent innovative activities that can be further developed into scalable rehabilitation services. They also create opportunities for collaboration with digital-health providers, clinical exercise physiology networks, and healthcare organizations interested in implementing accessible, evidence-based exercise support throughout the cancer treatment continuum.
Importantly, the project focuses on a largely overlooked patient population - individuals with advanced-stage colorectal cancer and liver metastases - providing valuable insights into this specific, vulnerable patient group. The output of this project will generate evidence to inform the further development of tailored exercise prescription in patients with metastatic colorectal cancer, an area in which robust, dose-specific guidance is currently lacking.
A key innovation of the project is the decentralized delivery of the exercise intervention. Facilitation of supervised exercise sessions via online platforms enhances accessibility for patients living in remote locations, in geographical areas outside main cities, who would otherwise be unable to participate due to travel constrains.
Moreover, since geographical location is often associated with socioeconomical and educational disparities, expanding access across wider regions helps promote equity among patients with cancer.
Collectively, the dose-response framework, the specific patient population, and the decentralized delivery approach represent innovative activities that can be further developed into scalable rehabilitation services. They also create opportunities for collaboration with digital-health providers, clinical exercise physiology networks, and healthcare organizations interested in implementing accessible, evidence-based exercise support throughout the cancer treatment continuum.