TY  - JOUR
AU  - Neu, Marie Astrid
AU  - Dreismickenbecker, Elias
AU  - Lanfranconi, Francesca
AU  - Stössel, Sandra
AU  - Balduzzi, Adriana
AU  - Wright, Peter
AU  - Windsor, Stan
AU  - Wiskemann, Joachim
AU  - El-Rajab, Inaam
AU  - Lucia, Alejandro
AU  - Fiuza-Luces, Carmen
AU  - Mongondry, Rodolf
AU  - Fridh, Martin Kaj
AU  - Spreafico, Filippo
AU  - Konda, Barbara
AU  - Kitanovski, Lidija
AU  - Heißerer, Barbara
AU  - Polak, Marco
AU  - Baader, Tobias
AU  - Bloch, Wilhelm
AU  - Götte, Miriam
AU  - Rizvi, Katie
AU  - Ruckes, Christian
AU  - Paul, Norbert W
AU  - Faber, Joerg
TI  - 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.
JO  - BMC cancer
VL  - 25
IS  - 1
SN  - 1471-2407
CY  - London
PB  - BioMed Central
M1  - DKFZ-2025-01645
SP  - 1275
PY  - 2025
N1  - Wiskemann D120 ?
AB  - Despite substantial advances in treatment, children and adolescents with cancer continue to face high morbidity and health issues, including cancer-related fatigue, treatment-related complications, and physical inactivity. Integrating exercise into pediatric oncology care has emerged as a promising approach to mitigate these burdens during cancer treatment. While preliminary data support its potential to reduce treatment-related side effects and enhance quality of life, robust evidence -especially from large, multicenter trials- remains limited.The FORTEe trial is a randomized, controlled, multicenter trial evaluating a personalized and standardized exercise intervention powered to include 450 children, adolescents, and young adults undergoing cancer treatment across ten centers in Europe. The trial aims to provide high-quality evidence for integrating precision exercise therapy as part of standard care. Participants are randomly assigned to either the exercise intervention group, receiving a tailored, supervised 8-10 weeks lasting exercise program, or the control group, receiving usual care. The exercise program includes endurance, strength, flexibility, and balance training, adapted to each patient's age, fitness, and cancer treatment phase. Exercise sessions are intended to take place 3-5 times a week with moderate intensity, with both frequency and intensity adapted to the clinical condition of the individual. Digital tools and telehealth solutions support the intervention, allowing for both in-person and remote training.With a target enrolment of 450 patients, the FORTEe trial will be one of the largest interventional studies in pediatric exercise oncology. Given that childhood cancer is a rare disease, this sample size is only achievable through a multicenter approach. Enhancing statistical power, the large sample will enable more robust analyses of the intervention's effects in a diverse population across multiple European centers.As a progress beyond the current state-of-the-art, FORTEe has the ambition to implement pediatric exercise oncology as an evidence-based treatment option for all childhood cancer patients, ultimately integrating it as a standard into clinical practice worldwide.The FORTEe trial was prospectively registered in the German Clinical Trials Register (DRKS00027978) on 28 January 2022 and on ClinicalTrials.gov (NCT05289739) on 21 March 2022.
KW  - Humans
KW  - Adolescent
KW  - Child
KW  - Neoplasms: therapy
KW  - Exercise Therapy: methods
KW  - Quality of Life
KW  - Randomized Controlled Trials as Topic
KW  - Male
KW  - Female
KW  - Young Adult
KW  - Multicenter Studies as Topic
KW  - Cancer-related fatigue (Other)
KW  - Childhood cancer (Other)
KW  - Exercise intervention (Other)
KW  - Pediatric Oncology (Other)
KW  - Physical activity (Other)
KW  - Randomized controlled trial (Other)
KW  - Supportive Care (Other)
KW  - Training (Other)
LB  - PUB:(DE-HGF)16
C6  - pmid:40775303
DO  - DOI:10.1186/s12885-025-14489-y
UR  - https://inrepo02.dkfz.de/record/303420
ER  -