Status:
ACTIVE_NOT_RECRUITING
Exercise Training in Childhood Cancer
Lead Sponsor:
Johannes Gutenberg University Mainz
Collaborating Sponsors:
University Hospital Heidelberg
Centre Leon Berard
Conditions:
Pediatric Oncology
Eligibility:
All Genders
4-21 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT05289739
Start Date
April 25 2022
End Date
August 31 2026
Last Update
September 3 2025
Active Locations (1)
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1
Johannes-Gutenberg-University Medical Center
Mainz, Rhineland-Palatinate, Germany, 55131