Trial Information

Physical Activity in Pediatric Cancer Patients With Solid Tumor Trial

Sixty patients, of both sexes, children will be recruited for this trial with an age range
between 4 to 16 years old, undergoing treatment for primary tumors (excluding central
nervous system tumors). Each participant will be assigned randomly (with blocking on sex) to
either intervention or control (usual care) group.

The intervention group will participate in combined inpatient physical training (aerobic +
strength) over neoadjuvant chemotherapy. The intervention will include three weekly exercise
sessions of 60-90 minutes, and will be held in child's room or in a pediatric gym
specifically enabled on the aforementioned hospital, depending on the children's health
status.

Primary outcomes [cardio-respiratory capacity (peak oxygen uptake), muscle strength (6RM leg
and bench press, and lateral row), functional capacity ('Timed Up and Down Stairs test',
and '3 m and 10m Time Up and Go tests'), physical activity levels (determined by
accelerometry) and quality of life "Child Report Form of the Child's Health and Illness
Profile-Child Edition", Adolescent Edition and Parents Report Form )] and secondary outcomes
[immune function (immune cell subpopulations, natural killer cells' cytotoxicity) and
inflammatory profile (blood levels of 47 cytokines)] will be measured in both groups in the
following time points:

(i) before the exercise intervention (immediately after diagnosis and before the start of
treatment); (ii) after the exercise intervention (upon termination of neoadjuvant
chemotherapy); and iii) after a detraining period (2 months after the intervention).