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Exercise in Adolescents With Cancer

Study acronym: EXERCADOL
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Secondary endpoints revised (115)v9
  2. Minor 2 versions Re-verified since Apr 29, 2026, no change to tracked fieldsv7-v8
  3. Notable Primary endpoints: 6 to 3
    • Secondary endpoints: 112 to 115
    • Study title shortened, about 1 word
    v6
  4. Notable Primary completion date: May 31, 2026 to Dec 31, 2026v5 Show 6 more changesShow less
    • Start date: Sep 15, 2022 to Apr 15, 2022
    • Interventions: lifestyle and physical exercise (Behavioral) to Physical exercise (Behavioral)
    • Secondary endpoints: 83 to 112
    • Study description expanded, about 22 words
    • Site details revised at 1 of 2 sites
    • Study title shortened, about 1 word
  5. Notable Primary endpoints: 4 to 6v4 Show 4 more changesShow less
    • Primary completion date: Dec 31, 2025 to May 31, 2026
    • Study completion date: Mar 31, 2026 to Dec 31, 2026
    • Secondary endpoints: 68 to 83
    • Study description shortened, about 16 words
Show 2 earlier versionsHide 2 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv3
  2. Notable Trial status: Not Yet Recruiting to Recruitingv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05539794
Lead Sponsor Universidad Europea de Madrid
Conditions
(from sponsor)
Adolescent Cancer
Related terms Neoplasms
Enrollment 136 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov