Clinical trial NCT06300515: Exercise and Health Counseling in Pediatric Hematopoietic Stem Cell Transplantation
Official title: Physical Exercise and Health Counseling in Patients With Pediatric Cancer Patients Undergoing Hematopoietic Stem Cell Transplantation: From Research to Clinical Reality.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic System--Cancer
Keywords: exercise
pediatric cancer
health counseling
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
Collaborators: name: Hospital Infantil Universitario Niño Jesús, Madrid, Spain
name: Hospital General Universitario Gregorio Marañon
name: Hospital Universitario La Paz
name: Hospital Universitario 12 de Octubre
First posted: 2024-03-08
Enrollment: 48
Sex: ALL
Minimum age (years): 4
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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 physical-functional, behavioral, psycho-cognitive and clinical outcomes, and blood biomarkers. The investigators will also determine to what extent the benefits of this intervention are maintained over time. Additionally, the investigators will determine the feasibility of implementing the proposed intervention in a real clinical situation in 3 different pediatric HSCT units.

Detailed description: Hematopoietic stem cell transplantation (HSCT), which is used to treat high-risk malignancies, as well as some other conditions or even autoimmune processes, consists of several phases: mobilization and subsequent collection of hematopoietic stem cells from the patient (autologous HSCT) or from a donor (allogeneic HSCT); pre-HSCT conditioning; infusion of patient/donor cells; establishment of a new immune and hematopoietic system in the recipient; and prophylaxis/treatment of possible adverse effects. Since the first successful allogeneic transplant was performed in 1968, thanks to the advances experienced in conditioning regimens, as well as in donor-recipient histocompatibility testing, in patient care and in the management of graft versus host disease (GvHD), together with the increase in the number of donors, the expectations of children and adolescents who receive HSCT have improved, achieving long-term survival rates (\>5 years) \>70%. Yet survivors are at high risk of suffering side effects and toxicities derived from the HSCT itself and/or the underlying disease, with subsequent functional decline. In addition, they show a higher risk of rehospitalization than pediatric cancer survivors who did not receive HSCT and tend to develop chronic pathologies (especially cardiometabolic conditions and frailty) at earlier stages of adulthood than the general population.

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 the following outcomes assessed at 3 time points \[start of hospitalization for HSCT (i.e., baseline), and 8 weeks and 3 months after hospital discharge, respectively\]: cardiorespiratory fitness (primary outcome) and ventilatory threshold, muscle strength, left ventricle ejection fraction, fractional shortening and global longitudinal strain, total cardiac mass, functional mobility, adiposity (waist to hip ratio), body mass index, dual-energy X-ray absorptiometry (DXA)-determined body composition (lean and fat mass, bone mineral density), accelerometry-determined physical activity levels, ankle dorsiflexion range of motion, health-related quality of life, cancer-related fatigue, and immune subpopulations. We will also determine clinical outcomes during hospitalization (survival, treatment tolerability, toxicities) as well as molecular biomarkers in blood.

Eligibility 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.
* 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.

Primary outcomes:
measure: Change in objectively-assessed cardiorespiratory fitness (CRF) from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in estimated cardiorespiratory fitness (CRF) from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
Secondary outcomes:
measure: Change in isometric leg muscle strength from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in dynamic lower-limb muscle strength from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in upper-limb muscle strength from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in respiratory muscle strength from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in the 'ventilatory threshold' (VT) from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in left ventricle (LV) ejection fraction from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in left ventricle (LV) fractional shortening from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in left ventricle (LV) global longitudinal strain (GLS) from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in total cardiac mass from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in functional mobility (stairs test) from baseline to follow-uo
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in functional mobility (chair rising) from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in functional mobility (Quick Function test) from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in body mass index (BMI) from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in adiposity index from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in dual-energy X-ray absorptiometry (DXA) measures of total lean mass from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in dual-energy X-ray absorptiometry (DXA) measures of total fat mass from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in dual-energy X-ray absorptiometry (DXA) measures of bone health from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in physical activity (PA) from baseline to end of treatment
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in ankle-dorsiflexion from baseline to end of treatment
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in psychological status (health-related quality of life) from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in psychological status (fatigue) from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in lymphocyte subpopulations from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in immune phenotype from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in survival from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in treatment tolerability from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in treatment toxicities from baseline to follow-up
timeFrame: Assessed at three time points: (1) start of hospitalization for HSCT (i.e., baseline); (2) 8 weeks after hospital discharge; and (3) 3 months after hospital discharge (i.e., follow-up)
measure: Change in the 'acute' molecular response to a single exercise session from baseline to 8 weeks after hospital discharge
timeFrame: Assessed at two time points: (1) start of hospitalization for HSCT (i.e., baseline); and (2) 8 weeks after hospital discharge.
measure: Change in the 'chronic' (resting conditions) transcriptome from baseline to 8 weeks after hospital discharge
timeFrame: Assessed at two time points: (1) start of hospitalization for HSCT (i.e., baseline); and (2) 8 weeks after hospital discharge.
measure: Change in the 'acute' transcriptome response to a single exercise session from baseline to 8 weeks after hospital discharge
timeFrame: Assessed at two time points: (1) start of hospitalization for HSCT (i.e., baseline); and (2) 8 weeks after hospital discharge.
measure: Change in the 'acute' transcriptome response from baseline to 8 weeks after hospital discharge
timeFrame: Assessed at two time points: (1) start of hospitalization for HSCT (i.e., baseline); and (2) 8 weeks after hospital discharge.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
Study officials:
References: