Exercise and lifestyle support for adolescents with cancer
Exercise Intervention for Adolescents With Cancer (EXERCADOL): A Randomized Controlled Trial
NA · Universidad Europea de Madrid · NCT05539794
This study is testing whether an exercise program and lifestyle support can help teenagers with cancer feel better during their treatment compared to standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 12 Years to 19 Years |
| Sex | All |
| Sponsor | Universidad Europea de Madrid (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Villaviciosa de Odón, Spain and 1 other locations) |
| Trial ID | NCT05539794 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of an in-hospital exercise program combined with lifestyle and dietary counseling on adolescents undergoing treatment for cancer. Participants aged 12-19, newly diagnosed with malignant extracranial tumors, will be randomly assigned to either an intervention group receiving exercise and counseling or a control group receiving standard care. The trial aims to assess various health-related outcomes over a treatment period of 5-6 months. The study will take place in three hospitals in Madrid, Spain, and will include at least 136 participants.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-19 years, newly diagnosed with a malignant extracranial tumor and in adequate health status.
Not a fit: Patients with a life expectancy of less than 3 months or those with comorbidities contraindicating exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve the cardiometabolic health and overall well-being of adolescents undergoing cancer treatment.
How similar studies have performed: Previous studies have shown positive outcomes from exercise interventions in childhood cancer, but this specific focus on adolescents is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Villaviciosa de Odón, Spain and 1 other locations
- Universidad Europea de Madrid — Villaviciosa de Odón, Spain, Spain (RECRUITING)
- UEM — Madrid, Spain (RECRUITING)
Study contacts
- Study coordinator: Alejandro Lucia
- Email: alejandro.lucia@universidadeuropea.es
- Phone: +34661393101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adolescent Cancer, cancer, lifestyle, cardiac function