| NCT ID | NCT05539794 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad Europea de Madrid |
| Condition | Adolescent Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2022-04-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 136 participants in total. It began in 2022-04-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators will study the effects of an supevised exercise intervention along the duration of intensive treatment (neoadjuvant \[solid tumours\]/intense chemotherapy \[leukemias\], expected median duration 5-6 months) on several health-related variables. Participants will be recruited from 4 hospitals in Madrid (Spain). Inclusion criteria: male/female aged 12-19 years, newly diagnosed--or relapse of-- a malignant extracranial tumour; not having received any type of therapy--except surgery--at the time of diagnosis; adequate health status (Karnofsky/Eastern Cooperative Oncology Group scale score ≥50/≤2); to understand Spanish language and to provide written informed consent. The investigators will recruit ≥136 participants and conduct a randomised controlled trial. The intervention group will follow a supervised concurrent exercise program from the start to the end of intensive treatment. The exercise intervention will be performed in the hospital gymnasium or in the patients' ward (during neutropenic phases), and will also include supervised online sessions. Additionally, the intervention group will perform include inspiratory muscle training. The following outcomes will be assessed at baseline (diagnosis), end of treatment, and at 3-month follow-up in all participants: echocardiography-determined left ventricular function (primary outcome); and other echocardiography-determined variables, cardiac biomarkers, blood pressure, blood lipids, body composition, physical activity levels, energy intake, cardiorespiratory fitness, muscle strength, functional mobility, health-related quality of life, cancer-related fatigue, clinical variables, and potential biological underpinnings of exercise multisystemic benefits (metabolic and inflammatory markers, plasma proteome, gut microbiome, and immune function).
Eligibility Criteria
Inclusion Criteria: * Newly diagnosed with a malignant extracranial tumour * Not having received any therapy--except surgery--at diagnosis * Adequate health status (Karnofsky/Eastern Cooperative Oncology Group scale score ≥50/2) * To understand Spanish language and provide written informed consent. Exclusion Criteria: * Life expectancy \<3 months * Comorbidity/acute condition contraindicating exercise practice
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05539794 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 19 Years, studying Adolescent Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05539794 currently recruiting?
Yes, NCT05539794 is actively recruiting participants. Contact the research team at alejandro.lucia@universidadeuropea.es for enrollment information.
Where is the NCT05539794 trial being conducted?
This trial is being conducted at Villaviciosa de Odón, Spain, Madrid, Spain.
Who is sponsoring the NCT05539794 clinical trial?
NCT05539794 is sponsored by Universidad Europea de Madrid. The trial plans to enroll 136 participants.
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