Exercise Training in Childhood Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-25

Study Completion Date

2026-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pediatric Oncology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise group

Usual medical care + supervised exercise training during intensive medical treatment

Group Type EXPERIMENTAL

Exercise training

Intervention Type BEHAVIORAL

Exercise training during intensive cancer treatment. Training mainly consists of age-appropriate and personalized endurance, strength, flexibility, balance/coordination and gait training. Three to five weekly training sessions lasting 30 to 60 minutes each for about eight to ten weeks (depending on the course of the cancer treatment).

Control group

Usual medical care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise training

Exercise training during intensive cancer treatment. Training mainly consists of age-appropriate and personalized endurance, strength, flexibility, balance/coordination and gait training. Three to five weekly training sessions lasting 30 to 60 minutes each for about eight to ten weeks (depending on the course of the cancer treatment).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No