Hematopoietic System--Cancer Clinical Trial
— HENKOOfficial title:
Physical Exercise and Health Counseling in Patients With Pediatric Cancer Patients Undergoing Hematopoietic Stem Cell Transplantation: From Research to Clinical Reality.
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.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | December 31, 2026 |
Est. primary completion date | March 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 21 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital 12 de Octubre | Madrid |
Lead Sponsor | Collaborator |
---|---|
Alejandro Lucia | Hospital General Universitario Gregorio Marañon, Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Hospital Universitario 12 de Octubre, Hospital Universitario La Paz |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in objectively-assessed cardiorespiratory fitness (CRF) from baseline to follow-up | CRF assessed as peak oxygen uptake, as determined during a ramp bicycle ergometer test until volitional exhaustion (unit = mL of oxygen/kg body mass/minute), | 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) | |
Primary | Change in estimated cardiorespiratory fitness (CRF) from baseline to follow-up | CRF estimated with 6-minute walking distance (maximum distance achieved) (unit = meters) | 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 | Change in isometric leg muscle strength from baseline to follow-up | Dynamometer-determined maximal isometric strength of knee flexor muscles (unit = Newtons) | 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 | Change in dynamic lower-limb muscle strength from baseline to follow-up | One-repetition maximum (1RM) during leg press exercise, as estimated from 5RM leg press (unit = kg) | 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 | Change in upper-limb muscle strength from baseline to follow-up | Maximal handgrip strength, mean of 3 attempts with both arms (unit = kg) | 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 | Change in respiratory muscle strength from baseline to follow-up | Maximal inspiratory pressure (unit = mm H20) | 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 | Change in the 'ventilatory threshold' (VT) from baseline to follow-up | Workload eliciting the ventilatory threshold, as determined during the ramp test (unit = watts) | 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 | Change in left ventricle (LV) ejection fraction from baseline to follow-up | Echocardiography-determined LV ejection fraction (unit = percent) | 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 | Change in left ventricle (LV) fractional shortening from baseline to follow-up | Echocardiography-determined LV fractional shortening (unit = percent) | 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 | Change in left ventricle (LV) global longitudinal strain (GLS) from baseline to follow-up | Echocardiography-determined GLS of the LV (unit = percent) | 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 | Change in total cardiac mass from baseline to follow-up | Echocardiography-determined total cardiac mass (unit = grams divided by body surface area (im meters squared) | 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 | Change in functional mobility (stairs test) from baseline to follow-uo | Stairs test (time to walk up and down a 12-step stair) (unit = seconds) | 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 | Change in functional mobility (chair rising) from baseline to follow-up | Sit-stand test (time to stand from a chair 5 times) (unit = seconds) | 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 | Change in functional mobility (Quick Function test) from baseline to follow-up | We will use the Quick Motor Function test, which takes approximately 10 to 15 minutes. An evaluator observes the performance of a patient and scores the 16 items separately on a 5-point ordinal scale (ranging from 0 to 4). If items can be performed on both left and right extremities, the right side is taken. A total score is obtained by adding the scores of all items. The total score ranges between 0 and 64 points (units = points, from 0 to 64) | 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 | Change in body mass index (BMI) from baseline to follow-up | BMI is measured as weight (kg) divided by height squared (m2) | 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 | Change in adiposity index from baseline to follow-up | Waist-to-hip ratio (no units) | 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 | Change in dual-energy X-ray absorptiometry (DXA) measures of total lean mass from baseline to follow-up | DXA-determined total lean mass (grams) | 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 | Change in dual-energy X-ray absorptiometry (DXA) measures of total fat mass from baseline to follow-up | DXA-determined total fat mass (grams) | 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 | Change in dual-energy X-ray absorptiometry (DXA) measures of bone health from baseline to follow-up | DXA-determined bone mineral density (unit = grams/m2) | 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 | Change in physical activity (PA) from baseline to end of treatment | PA levels (moderate/vigorous PA) determined using triaxial accelerometry (unit = minutes/week) | 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 | Change in ankle-dorsiflexion from baseline to end of treatment | Goniometer-determined active and passive ankle range of motion in dorsiflexion (unit = degrees) | 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 | Change in psychological status (health-related quality of life) from baseline to follow-up | Health-related QoL (HRQoL) (Paediatric Quality of Life Inventory [abbreviated as PedsQL 4.0] Cancer Module [3.0], designed to measure paediatric/adolescent cancer specific HRQoL) (unit = 0 to 100 scale, with higher scores indicating better HRQoL) | 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 | Change in psychological status (fatigue) from baseline to follow-up | Cancer-related fatigue (Paediatric Quality of Life (PedsQL 3.0) Multidimensional Fatigue Scale) (0 to 100 score, higher scores meaning higher fatigue) | 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 | Change in lymphocyte subpopulations from baseline to follow-up | Flow-cytometry determined lymphocyte subpopulations (unit = %) | 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 | Change in immune phenotype from baseline to follow-up | Flow-cytometry determined natural killer (NK) cell subsets (unit = %) | 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 | Change in survival from baseline to follow-up | Survival (number of days from diagnosis to the end of the study or death) | 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 | Change in treatment tolerability from baseline to follow-up | Treatment interruption/delay (number of days) | 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 | Change in treatment toxicities from baseline to follow-up | Common Toxicity Criteria for Adverse Events [CTCAE, global score, 1 (low toxicity) to 5 (highest]) | 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 | Change in the 'acute' molecular response to a single exercise session from baseline to 8 weeks after hospital discharge | Panel of cytokines/chemokines and peptides (oncostatin-M, osteonectin, FGF21, irisin, follistatin-1, musclin, VEGF-A, fractalkine, interleukin (IL)-8, IL-6 and IL-15 in serum using Luminex® (all assessed in the same units, micrograms/dL) before and after a single exercise training session | Assessed at two time points: (1) start of hospitalization for HSCT (i.e., baseline); and (2) 8 weeks after hospital discharge. | |
Secondary | Change in the 'chronic' (resting conditions) transcriptome from baseline to 8 weeks after hospital discharge | RNA sequencing (RNAseq) profile in peripheral blood mononuclear cells under resting conditions at baseline and 8 weeks after hospital discharge | Assessed at two time points: (1) start of hospitalization for HSCT (i.e., baseline); and (2) 8 weeks after hospital discharge. | |
Secondary | Change in the 'acute' transcriptome response to a single exercise session from baseline to 8 weeks after hospital discharge | RNA sequencing (RNAseq) profile in peripheral blood mononuclear cells before and after a single exercise training session | Assessed at two time points: (1) start of hospitalization for HSCT (i.e., baseline); and (2) 8 weeks after hospital discharge. | |
Secondary | Change in the 'acute' transcriptome response from baseline to 8 weeks after hospital discharge | RNA sequencing (RNAseq) profile in peripheral blood mononuclear cells before and after and exercise training session | Assessed at two time points: (1) start of hospitalization for HSCT (i.e., baseline); and (2) 8 weeks after hospital discharge. |
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