Exercise in Adolescents With Cancer

Recruiting now · Not applicable

Conditions studied: Adolescent Cancer

In brief

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).

Key facts

Study ID

NCT05539794

Run by

Universidad Europea de Madrid

People needed

136

Starts

2022-04-15

Expected to finish

2026-12-31

Last updated by the study team

2026-07-22

Who can join

Age: 12 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Life expectancy <3 months
• Comorbidity/acute condition contraindicating exercise practice

Where it is running

• Universidad Europea de Madrid — Villaviciosa de Odón, Spain, Spain (enrolling)
• UEM — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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