In a groundbreaking advancement for pediatric oncology, researchers have launched the FORTEe trial—a robust, multicenter randomized controlled study designed to evaluate the therapeutic impact of a structured exercise program for children and adolescents undergoing anti-cancer treatments. This pivotal research aims to address a significant, yet often overlooked, aspect of childhood cancer care: the severe physical and psychological toll inflicted by both the disease and its rigorous treatment regimens. With the FORTEe trial, scientists hope to establish exercise not merely as complementary support but as a standardized, evidence-based intervention integrated into routine pediatric oncology protocols.
Despite remarkable progress in pediatric oncology treatments over recent decades, children and adolescents battling cancer often endure persistent challenges such as debilitating fatigue, reduced physical function, and a spectrum of treatment-related complications. These issues collectively contribute to a diminished quality of life and long-term health consequences that may extend well beyond remission. The traditional focus on eradicating malignancy, while critical, has sometimes overshadowed the necessity for adjunct therapies that directly mitigate these side effects. The FORTEe trial emerges against this backdrop, driven by the hypothesis that precision-tailored exercise regimens can profoundly enhance patients’ resilience, functional capacity, and overall wellbeing during active cancer treatment.
The design of the FORTEe trial reflects a meticulous and ambitious strategy. Spanning ten major centers across Europe, the trial plans to recruit 450 children, adolescents, and young adults undergoing active cancer therapy—making it one of the largest studies of its kind in pediatric exercise oncology. Such sample size and geographic diversity not only bolster the statistical power of the findings but also accommodate the heterogeneity inherent in pediatric cancers and patient populations. This multi-institutional collaboration underscores a growing international consensus recognizing the potential of exercise interventions to transform supportive cancer care.
Participants in the trial are randomly assigned to one of two groups: the intervention arm, which receives an individualized, supervised exercise program tailored to patient age, cancer type, and treatment stage; or a control arm receiving standard care without structured exercise. This dichotomy ensures a rigorous comparative framework to isolate the effects of exercise itself. The intervention is designed to span 8 to 10 weeks, involving 3 to 5 sessions weekly, blending endurance, strength, flexibility, and balance components. Importantly, the exercise respects the patients’ fluctuating clinical status by adapting intensity and frequency, ensuring safety while maximizing therapeutic benefits.
Underpinning the FORTEe trial is a commitment to precision exercise medicine—a concept that mirrors the personalized approaches increasingly prevalent in pharmacologic oncology. Individualized exercise prescriptions consider the unique physiological and psychosocial characteristics of each patient, including cancer type, treatment regimen, baseline fitness, and ongoing symptoms. This personalized approach attempts to optimize tolerability and efficacy, eschewing a one-size-fits-all model that may fail to meet the nuanced needs of children undergoing complex medical treatments.
Technological integration forms another cornerstone of the FORTEe trial. By harnessing digital tools and telehealth platforms, the research expands access and adaptability of exercise interventions. Remote monitoring and virtual supervision enable continuous engagement even when hospital visits are limited or when patients remain immunocompromised. This digital augmentation facilitates real-time feedback, adherence monitoring, and adjustment of exercise parameters, ensuring that interventions are responsive to patients’ evolving conditions and logistical constraints.
The importance of the FORTEe trial also lies in its potential to generate high-quality evidence within a field currently hindered by a paucity of large-scale, randomized data. While prior smaller and observational studies have hinted at the benefits of exercise during pediatric cancer treatment, definitive conclusions remain elusive due to limited sample sizes, methodological variability, and heterogeneous settings. FORTEe’s robust design anticipates filling this evidence gap, offering generalizable insights that can shape clinical guidelines and policy frameworks worldwide.
Another critical feature of the FORTEe approach is its holistic view of health, recognizing that exercise can influence not only physical outcomes but also psychological resilience. Cancer-related fatigue, emotional distress, and social isolation represent profound challenges for young patients. Exercise therapy, as an accessible and non-pharmacological modality, carries the promise of bolstering mood, self-efficacy, and social engagement, thereby addressing multifaceted dimensions of quality of life.
The trial’s timing is particularly opportune given the increasing survivorship rates in pediatric oncology. As more children survive cancer, attention has shifted towards survivorship care and the mitigation of long-term sequelae such as cardiopulmonary dysfunction, musculoskeletal deficits, and secondary malignancies. Early incorporation of exercise during treatment might alter the trajectory of recovery and chronic health outcomes, establishing healthier baselines and promoting active lifestyles that continue beyond the hospital setting.
Executing a multicenter trial of this scale in pediatric exercise oncology also demands intricate logistical coordination and interdisciplinary collaboration. Coordinating patient recruitment, standardized intervention delivery, data harmonization, and adherence tracking across ten European sites requires meticulous protocols and dedicated expertise ranging from oncologists and exercise physiologists to data scientists and telehealth specialists. The trial exemplifies the power of collaborative research networks to confront complex clinical challenges through unified scientific endeavors.
Moreover, the adaptability of the exercise program acknowledges the clinical realities faced by pediatric oncology patients, whose conditions may fluctuate rapidly due to treatment toxicities or disease progression. By designing flexible exercise prescriptions adjusted to real-time health status, researchers aim to maximize participant safety—one of the paramount concerns when introducing physical activity amidst potent medical treatments.
From a mechanistic perspective, exercise has been shown in various adult and pediatric studies to modulate inflammatory pathways, enhance immune function, and stimulate neurohormonal adaptations that may be protective during cancer therapy. While the exact biological mediators in the pediatric context require further elucidation, this trial’s findings could stimulate mechanistic research that clarifies how exercise exerts its systemic effects during anti-cancer treatment.
The FORTEe trial is prospectively registered in recognized clinical trial registries, ensuring transparency and methodological rigor. Such registration not only strengthens the credibility of results but also facilitates dissemination within the global research community, promoting timely translation of evidence into practice.
In sum, the FORTEe trial stands at the forefront of a paradigm shift in pediatric oncology—transcending traditional notions of treatment to incorporate holistic, personalized exercise interventions as a core component of anti-cancer therapy. Should the trial’s results confirm its hypotheses, the implications could be transformative: pediatric exercise oncology may emerge as a new standard of care, reducing morbidity, improving functional outcomes, and ultimately enhancing the lives of countless children and adolescents fighting cancer around the world.
This research embodies a hopeful vision for pediatric cancer care—where physical strength, mental resilience, and cutting-edge medicine converge to redefine survivorship and health beyond cancer. The results, eagerly awaited by clinicians, patients, and families alike, hold the promise to shape the future landscape of pediatric oncology, offering young patients a powerful tool in their fight against cancer.
Subject of Research: Exercise intervention for children and adolescents undergoing anti-cancer treatment
Article Title: Get strong to fight childhood cancer – an exercise intervention for children and adolescents undergoing anti-cancer treatment (FORTEe): Rationale and design of a randomized controlled exercise trial
Article References: Neu, M.A., Dreismickenbecker, E., Lanfranconi, F. et al. Get strong to fight childhood cancer – an exercise intervention for children and adolescents undergoing anti-cancer treatment (FORTEe): Rationale and design of a randomized controlled exercise trial. BMC Cancer 25, 1275 (2025). https://doi.org/10.1186/s12885-025-14489-y
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