Actively Recruiting

Phase Not Applicable
Age: 12Years - 19Years
All Genders
NCT05539794

Exercise in Adolescents With Cancer

Led by Universidad Europea de Madrid · Updated on 2026-05-05

136

Participants Needed

2

Research Sites

245 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Exercise in Adolescents With Cancer

Who Can Participate

Age: 12Years - 19Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 650/ 62)
  • Able to understand Spanish and provide written informed consent
Not Eligible

You will not qualify if you...

  • Life expectancy less than 3 months
  • Comorbidity or acute condition that contraindicates exercise practice

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Trial Site Locations

Total: 2 locations

1

Universidad Europea de Madrid

Villaviciosa de Odón, Spain, Spain, 28670

Actively Recruiting

2

UEM

Madrid, Spain

Actively Recruiting

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Research Team

A

Alejandro Lucia

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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