Exercise and health counseling for children undergoing stem cell transplants
Official title: Exercise Intervention in Childhood and Adolescence Hematopoietic Stem Cell Transplantation: The Henkō Trial
Run by Universidad Europea de Madrid · NCT06300515 · Data updated 2026-11-12
This study is testing whether a program of exercise and health counseling can help children and teens undergoing stem cell transplants for cancer feel better and improve their quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Years to 21 Years |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Universidad Europea de Madrid Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Status | Recruiting |
| Started | April 1, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | August 24, 2026 |
| Trial ID | NCT06300515 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children and adolescents aged 4 to 21 who are undergoing HSCT for cancer and are able to provide informed consent.
✕Probably not a fit
Patients with severe comorbidities or acute conditions that contraindicate physical exercise may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of a physical exercise and health counseling program for children and adolescents aged 4 to 21 who are undergoing hematopoietic stem cell transplantation (HSCT) for cancer. The aim is to address the high risk of functional decline and chronic health issues that these patients face post-transplant. Participants will be recruited from three hospitals in Madrid, and the study will compare outcomes between an intervention group receiving exercise and counseling and a control group. The research seeks to establish a feasible and effective intervention to improve the quality of life for pediatric HSCT patients.
Why it matters
Potential benefit: If successful, this program could significantly enhance the physical health and quality of life for children recovering from stem cell transplants.
How similar studies have gone: While there is limited research on exercise interventions in this specific population, similar studies in other contexts have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 4 and 21 years. * Undergoing hematopoietic stem cell transplantation (HSCT) for cancer diagnosis in complete remission or without remission, in 3 recruiting Hospitals in Madrid * Undergoing treatment and follow-up in the same hospital. * Speaking Spanish. * Showing adequate baseline health status (Karnofsky \>50, Eastern Cooperative Oncology Group scale score \<2). * Providing signed informed consent. Exclusion Criteria: * Not being able to participate in the trial according to protocol. * Comorbidity or acute condition not associated with the diagnosis and that contraindicates the practice of physical exercise, such as severe deficiencies in the locomotor, neurological, cardiovascular and pulmonary systems. * Serious or chronic medical or psychiatric condition that may increase the risk associated with participation in the trial or that may interfere with the interpretation of the results and, in the opinion of the investigator in discussion with the team, makes having such condition inappropriate for entry to this study; inability to understand the study requirements. * Not being able to attend hospital visits to perform assessment tests, nor participate in the physical exercise and health counseling program as stipulated in the protocol. Inability to understand the requirements of the study.
Where it's running
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Hospital 12 de Octubre
Madrid, Madrid, Spain Recruiting
Study contacts
- Study coordinator: Carmen Fiuza-Luces, PhD
- Email: cfiuza.imas12@h12o.es
- Phone: +34658961509
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.