Exercise in Adolescents With Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-19
SponsorUniversidad Europea de Madrid

About this trial

The investigators will study the effects of an supevised exercise intervention along the duration of intensive treatment (neoadjuvant \[solid tumours\]/intense chemotherapy \[leukemias\], expected median duration 5-6 months) on several health-related variables. Participants will be recruited from 4 hospitals in Madrid (Spain). Inclusion criteria: male/female aged 12-19 years, newly diagnosed--or 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. The intervention group will follow a supervised concurrent exercise program from the start to the end of intensive treatment. The exercise intervention will be performed in the hospital gymnasium or in the patients' ward (during neutropenic phases), and will also include supervised online sessions. Additionally, the intervention group will perform include inspiratory muscle training. 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 echocardiography-determined variables, cardiac biomarkers, blood pressure, blood lipids, body composition, physical activity levels, energy intake, cardiorespiratory fitness, muscle strength, functional mobility, health-related quality of life, cancer-related fatigue, clinical variables, and potential biological underpinnings of exercise multisystemic benefits (metabolic and inflammatory markers, plasma proteome, gut microbiome, and immune function).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed with a malignant extracranial tumour

Not having received any therapy--except surgery--at diagnosis

Adequate health status (Karnofsky/Eastern Cooperative Oncology Group scale score ≥50/2)

To understand Spanish language and provide written informed consent.

Disqualifiers

Life expectancy <3 months

Comorbidity/acute condition contraindicating exercise practice

Trial design

Design model

Parallel

Treatments tested in this trial

  • Physical exercise

    Behavioral

    the intervention group will follow a supervised physical exercise intervention--see below. The exercise program (3 supervised sessions/week of aerobic and muscle strength exercises) will be performed: (a) in the hospital gymnasium, or (b) in the patients' room (during phases of treatment-induced immunodepression, where isolation is needed to prevent infections), or (c) online (for those unable to attend the hospital on that day/s). It will also include specific training of the respiratory ('inspiratory') muscles (e.g., diaphragm) on 5 days/week.

Treatment groups

136 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in left-ventricular (LV) function (LV ejection fraction) from baseline to end of treatment

Echocardiography-determined LV ejection fraction (unit = %)

Time frame
Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
2

Change in left-ventricular (LV) function (LV fractional shortening) from baseline to end of treatment

Echocardiography-determined LV fractional shortening (unit = %)

Time frame
Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
3

Change in global longitudinal strain (GLS) of the left ventricle from baseline to end of treatment

Echocardiography-determined GLS (%)

Time frame
Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)

Secondary outcomes

1

Change in left-ventricular (LV) function (LV ejection fraction) from baseline to follow-up

Echocardiography-determined LV ejection fraction (unit = %)

Time frame
Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
2

Change in left-ventricular (LV) function (LV fractional shortening) from baseline to follow-up

Echocardiography-determined LV fractional shortening (unit = %)

Time frame
Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)]
3

Change in global longitudinal strain (GLS) of the left ventricle from baseline to 3 months after the end of treatment (follow-up)

Echocardiography-determined GLS (%)

Time frame
Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
4

Change in 'clinic' arterial blood pressure from baseline to end of treatment

Arterial blood pressure (BP) (units = mmHg)

Time frame
Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis

Other outcomes

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