Completed

FORTEeInnovative Exercise Treatment for Improved Strength and Quality of Life in Children Undergoing Cancer Treatment

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to improve strength and quality of life in children undergoing cancer treatment through an innovative exercise regimen, with a primary focus on reducing cancer-related fatigue as measured by the Pediatric Quality of Life Inventory.

What is being tested

Exercise training

Behavioral
Who is being recruted

Neoplasms

From 4 to 21 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: April 2022
See protocol details

Summary

Principal SponsorJohannes Gutenberg University Mainz
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 25, 2022

Actual date on which the first participant was enrolled.

The FORTEe trial is a patient-centered study focused on children and adolescents undergoing cancer treatment. The main goal is to understand if supervised exercise can help increase muscle strength and reduce muscle loss due to bedrest. This could potentially improve quality of life and treatment efficiency, ultimately aiding in the fight against childhood cancer. The study also plans to use innovative technologies like augmented reality to make the exercise training more effective, age-appropriate, and personalized. The long-term aim is to establish exercise as a standard part of care for all childhood cancer patients across the EU and beyond.

Official TitleGet Strong to Fight Childhood Cancer: An Exercise Intervention for Children and Adolescents Undergoing Anti-Cancer Treatment
NCT05289739
Principal SponsorJohannes Gutenberg University Mainz
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

478 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 4 to 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neoplasms

Criteria

6 inclusion criteria required to participate
Planned or started anti-cancer treatment (chemo- and/or radiotherapy) at one of the recruiting centres of the FORTEe trial

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

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

Show More Criteria

6 exclusion criteria prevent from participating
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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Usual medical care + supervised exercise training during intensive medical treatment

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Johannes-Gutenberg-University Medical Center

Mainz, GermanyOpen Johannes-Gutenberg-University Medical Center in Google Maps
CompletedOne Study Center