Exercise Training in Childhood Cancer (FORTEe)

Johannes Gutenberg University (JGU)

Status

Active, not recruiting

Conditions

Pediatric Oncology

Treatments

Behavioral: Exercise training

Study type

Interventional

Funder types

Other

Identifiers

NCT05289739

UMC-Mainz: 21-00338

Details and patient eligibility

About

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

Full 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.

Enrollment

450 estimated patients

Sex

All

Ages

4 to 21 years old

Volunteers

No Healthy Volunteers

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