NCT06300515Recruiting
Exercise and Health Counseling in Pediatric Hematopoietic Stem Cell Transplantation
Exercise Intervention in Childhood and Adolescence Hematopoietic Stem Cell Transplantation: The Henkō Trial
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
Thanks to medical advances, survival rates \>5 years in children/adolescents undergoing hematopoietic stem cell transplant (HSCT) exceed 70%. However, these patients are at high risk of suffering sequelae associated with the underlying disease and/or the HSCT itself, which negatively affects their physical capacity. These patients also tend to spend too much time inactive, which further accelerates functional decline in addition to producing fatigue and impairing quality of life. Therefore, new strategies are needed to minimize the morbidity associated with HSCT. In this effect, although physical exercise represents an interesting adjuvant treatment option for HSCT, scientific evidence in this area is still scarce. Implementation of physical exercise intervention in pediatric HSCT units is challenging due to the lack of research on the effectiveness, affordability and accessibility of this type of intervention. Therefore, establishing the effectiveness of physical exercise under controlled conditions is an important step. The investigators therefore aim to assess the impact of a physical exercise and health counseling program, compared to health counseling only (control group), in pediatric patients with cancer undergoing HSCT on muscle strength (primary outcome), and several fitness/function, clinical burden (i.e., cardiac damage, treatment toxicities, health-related quality of life, among others) and biological variables (omics, blood immune phenotype, microbiome) (secondary outcomes). The investigators will also determine to what extent the benefits of this intervention are maintained over time. Additionally, the investigators will determine the intervention implementability in a real clinical situation in 3 different pediatric HSCT units.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 1 Mar 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Alejandro Lucia
- Diseases
- Childhood cancers
- NCT number
- NCT06300515
What you commit to
- Study type: Interventional
- Planned participants: 48
- From 1 Apr 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Not being able to participate in the trial according to protocol.
- 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.
Who the study is looking for
- 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.
Age in the registry: 4 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.