Clinical trial NCT05289739: Exercise Training in Childhood Cancer
Official title: Get Strong to Fight Childhood Cancer: An Exercise Intervention for Children and Adolescents Undergoing Anti-Cancer Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pediatric Oncology
Keywords: Paediatric exercise oncology
precision exercise training
childhood cancer
randomized controlled trial
quality of life
augmented reality
exercise technology
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: University Hospital Heidelberg
name: Centre Leon Berard
name: Oxford Brookes University
name: Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM)
name: European University of Madrid
name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: University Medical Centre Ljubljana
name: Rigshospitalet, Denmark
name: German Sport University, Cologne
name: University Hospital, Essen
First posted: 2022-03-21
Enrollment: 450
Sex: ALL
Minimum age (years): 4
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this multicenter study is to evaluate a personalised and standardised exercise intervention for children and adolescents undergoing anti-cancer treatment.

Detailed description: In the randomised, controlled FORTEe trial, high evidence for an innovative, patient-centred exercise treatment shall be generated. Supervised exercise training intents to increase muscle strength and reduce muscular atrophy due to bedrest. CRF and HRQoL can be improved and in the future, these benefits may help to fight childhood cancer by increasing therapy efficiency and survival rate. Within the project, digital, innovative technologies such as augmented reality will be developed and applied to make the exercise training more effective, age-adapted and personalised. Moreover, FORTEe will stimulate translational research to provide access to paediatric exercise oncology as a new health care intervention. As a progress beyond the current state-of-the-art, FORTEe has the ambition to implement paediatric exercise oncology as an evidence-based standard in clinical care for all childhood cancer patients across the EU and beyond.

Eligibility criteria: Inclusion criteria:

* First/initial diagnosis of a primary oncologic disease according to the International Classification of Childhood Cancer (ICCC), requiring chemotherapy and/or radiation therapy or First/initial diagnosis of a relapsed oncologic disease according to the International Classification of Childhood Cancer (ICCC), requiring chemotherapy and/or radiation therapy or First/initial diagnosis of a secondary oncologic disease according to the International Classification of Childhood Cancer (ICCC), requiring chemotherapy and/or radiation therapy
* Planned or started anti-cancer treatment (chemo- and/or radiotherapy) at one of the recruiting centres of the FORTEe trial
* The patient is assessed by the treating team (pediatric oncologist, exercise professional etc.) as suitable to participate in the trial, e.g. due to medical or psychological reasons.
* Existing informed consent (or assent) to participate in the study
* The patient (and the legal guardian) has/have sufficient knowledge of the respective national or English language so that it is possible to carry out the informed consent as well as interviews (in age-appropriate language).
* The patient is not in a terminal phase of the disease.

Exclusion criteria:

* Oncologic disease (primary/relapsed/secondary) according to the International Classification of Childhood Cancer (ICCC), requiring neither chemotherapy nor radiation therapy or solely requiring surgery
* Reasons that already exist or are foreseeable at the time of study enrolment, due to which the patient will not have access to the exercise intervention and/or to the pre-test and/or to the post-test (e.g. foreseeable or planned, permanent change of treatment centre)
* The patient is assessed by the treating team (pediatric oncologist, exercise professional etc.) as unsuitable to participate in the trial, e.g. due to medical or psychological reasons.
* After detailed information and, if necessary, having time to consider, the patient (≥ 16 years of age) did not agree to give written informed consent to participate in the trial.
* The patient (and the legal guardians) has/have insufficient knowledge of the respective national or English language, so that it is not possible to carry out both the informed consent and interviews (in age-appropriate language).
* The patient is in a terminal phase of the disease

Primary outcomes:
measure: Change in the score of Cancer-related fatigue during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
timeFrame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Secondary outcomes:
measure: Change in the score of general Health-Related Quality of Life during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
timeFrame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
measure: Change in the score of cancer-related Health-Related Quality of Life during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
timeFrame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
measure: Change in the score of Mental Health (measured by WHO (Five) Well-Being Index) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
timeFrame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
measure: Change in the score of Mental Health (measured by Warwick-Edinburgh Mental Well-being Scale (WEMWBS)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
timeFrame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
measure: Change in the score of Resilience (measured by Mainzer Resilience Scale for childhood cancer (MRScc)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
timeFrame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
measure: Change in the score of Resilience (measured by the Brief Resilience Scale (BRS)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
timeFrame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
measure: Change in the score of Resilience (measured by the Child & Youth Resilience Measure-Revised (CYRM-R)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
timeFrame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
measure: Change in the score of General self-efficacy during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
timeFrame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
measure: Change in the score of Physical exercise self-efficacy during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
timeFrame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
measure: Change in the Physical activity level (measured by the Modifed Recent Physical Activity Questionnaire (mRPAQ)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
timeFrame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
measure: Change in the Physical activity level (measured by the Modified Youth Physical Activity Questionnaire (mYPAQ)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
timeFrame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
measure: Change in the Physical activity level (measured by the Modified Children's Physical Activity Questionnaire (mCPAQ)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
timeFrame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
measure: Change in the Physical activity level and behaviour during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
timeFrame: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
measure: Change in functional capacity after the intervention and after a 12-week follow-up compared to baseline
timeFrame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
measure: Change in endurance performance (measured by the assisted 6-minute cycling test) after the intervention and after a 12-week follow-up compared to baseline
timeFrame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
measure: Change in endurance performance (measured by the adapted Yo-Yo-Test) after the intervention and after a 12-week follow-up compared to baseline
timeFrame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
measure: Longitudinal assessment of oxidative skeletal muscle impairment after the intervention and after a 12-week follow-up compared to baseline
timeFrame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
measure: Change in peak oxygen uptake (VO2peak) after the intervention and after a 12-week follow-up compared to baseline
timeFrame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
measure: Change in motor function after the intervention and after a 12-week follow-up compared to baseline
timeFrame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
measure: Change in hamstrings flexibility after the intervention and after a 12-week follow-up compared to baseline
timeFrame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
measure: Change in lower limbs flexibility after the intervention and after a 12-week follow-up compared to baseline
timeFrame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
measure: Change in functional strength after the intervention and after a 12-week follow-up compared to baseline
timeFrame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
measure: Change in arm strength after the intervention and after a 12-week follow-up compared to baseline
timeFrame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
measure: Change in upper body strength after the intervention and after a 12-week follow-up compared to baseline
timeFrame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
measure: Change in knee flexor strength after the intervention and after a 12-week follow-up compared to baseline
timeFrame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
measure: Change in leg extension strength after the intervention and after a 12-week follow-up compared to baseline
timeFrame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
measure: Change in functional mobility after the intervention and after a 12-week follow-up compared to baseline
timeFrame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
measure: Change in static balance after the intervention and after a 12-week follow-up compared to baseline
timeFrame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
measure: Change in body composition (measured via skinfold measurement) after the intervention and after a 12-week follow-up compared to baseline
timeFrame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
measure: Change of the phase angle by means of bioelectrical impedance analysis for the examination of body composition after the intervention and after a 12-week follow-up compared to baseline
timeFrame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
measure: Change in body composition (measured via dual-energy x-ray absorptiometry) after the intervention and after a 12-week follow-up compared to baseline
timeFrame: pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention
measure: Usage frequency of the augmented reality (AR) app from baseline to the end of app use
timeFrame: during the use of the app from baseline until the end of app use (15 months after the end of intervention)
measure: Usability of the augmented reality app
timeFrame: post app use (15 months after the end of intervention)
measure: Usability of the pixformance station
timeFrame: post app use (15 months after the end of intervention)
measure: Composite multidimensional socioeconomic status index
timeFrame: pre-intervention
measure: Change in the number of T-cells before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention
timeFrame: Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks)
measure: Change in the number of B-cells before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention
timeFrame: Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks)
measure: Change in the number of NK-cells before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention
timeFrame: Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks)
measure: Change in the number of leukocytes before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention
timeFrame: Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks)
measure: Change in the number of monocytes before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention
timeFrame: Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks)
measure: Change in the DNA methylation status of T cells before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention
timeFrame: Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks)
measure: Change in the DNA methylation status of NK cells before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention (baseline), pre-exercise intervention and post-exercise intervention
timeFrame: Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks)
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Johannes-Gutenberg-University Medical Center
state: Rhineland-Palatinate
Study officials:
affiliation: Johannes Gutenberg University Mainz
name: Jörg Faber, Univ.-Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: