Exercise in Adolescents With Cancer

Background. Health promotion interventions are needed during adolescent cancer treatment to facilitate the acquisition of good health practices as patients transition to survivorship. Although meta-analytical evidence supports the health benefits of exercise in the context of childhood cancer, there is scant data focusing solely on adolescents.

Hypothesis and objectives. The investigators hypothesise that a supervised exercise intervention combined with lifestyle counselling during treatment for adolescent cancer will provide several health benefits, particularly related to the cardiometabolic profile. Thus, the investigators will study the effects of a supervised exercise intervention along the duration of intensive treatment (neoadjuvant \[solid tumours\]/intense chemotherapy \[leukaemias\], expected median duration 5-6 months) on several health-related variables.

Setting and Methods. Participants will be recruited from 4 hospitals in Madrid (Spain). Inclusion criteria: male/female aged 12-19 years, newly diagnosed with (or having relapse of) a malignant extracranial tumour; not having received any type of therapy--except surgery--at the time of diagnosis; adequate health status (Karnofsky/Eastern Cooperative Oncology Group scale score ≥50/≤2); to understand Spanish language and to provide written informed consent. The investigators will recruit ≥136 participants and conduct a randomised controlled trial (1:1 ratio randomisation with a block on gender and tumour type \[leukaemias/lymphomas\]). In addition to usual care, the two groups will receive health counselling twice a month (i.e., psychological intervention based on motivational interviewing techniques, as well as guidance on heathy activity, sleeping, and dietary habits). The intervention group will follow a physical exercise and lifestyle counselling program. The exercise intervention will be performed in the hospital gymnasium (3 sessions/week of aerobic and resistance exercises), except for neutropenic phases--during which time sessions will be performed in the patients' ward--and will also include online sessions. Inspiratory muscle training (5 days/week) will be also performed. Patients in the control group will have the option to go to the hospital gymnasium twice a month (to perform playing activities) in order to maximize compliance to the study and to maintain contact with them. The following outcomes will be assessed at baseline (diagnosis), end of treatment, and at 3-month follow-up in all participants: echocardiography-determined left ventricular function (primary outcome); and other echocardiographic variables, cardiometabolic biomarkers, blood pressure, blood lipids, dual-energy X-ray absorptiometry-determined body composition (fat \[including visceral adipose tissue\]/lean mass, bone mineral content/density), energy intake, cardiorespiratory fitness, muscle strength, functional mobility, health-related quality of life, cancer-related fatigue, clinical variables (survival, treatment tolerability, hospitalisation length), and potential biological underpinnings of exercise multisystemic benefits (cardiometabolic and inflammatory biomarkers, gut microbiome, and immune function \[lymphocyte subpopulations, natural killer cell cytotoxicity\]) (secondary outcomes).

• Change in left-ventricular (LV) function (LV ejection fraction) from baseline to follow-up [Срок оценки: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)]
• Change in left-ventricular (LV) function (LV fractional shortening) from baseline to follow-up [Срок оценки: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)]]
• Change in global longitudinal strain (GLS) of the left ventricle from baseline to 3 months after the end of treatment (follow-up) [Срок оценки: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)]
• Change in 'clinic' arterial blood pressure from baseline to end of treatment [Срок оценки: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis]
• Change in 'clinic' arterial blood pressure from baseline to follow-up [Срок оценки: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)]
• Change in serum lipid profile (cholesterol) from baseline to end of treatment [Срок оценки: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis)]]
• Change in serum lipid profile (cholesterol) from baseline to follow-up [Срок оценки: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)]]
• Change in serum lipid profile (triglycerides) from baseline to end of treatment [Срок оценки: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis)]]
• Change in serum lipid profile (triglycerides) from baseline to follow-up [Срок оценки: Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)]]
• Change in adiposity index from baseline to end of treatment [Срок оценки: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)]
• Change in adiposity index from baseline to follow-up [Срок оценки: Assessed at two time points: (1) at baseline (diagnosis); (2) 3 months after the end of treatment (follow-up)]
• Change in DXA measures of lean mass from baseline to end of treatment [Срок оценки: Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)]