Exercise in Adolescents With Cancer (EXERCADOL)

NCT ID: NCT05539794

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2026-12-31

Brief Summary

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).

Detailed Description

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).

Conditions

Adolescent Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

The intervention group will follow a supervised physical exercise program.

Group Type: EXPERIMENTAL

Physical exercise

Intervention Type: 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.

Control

Standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical exercise

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Life expectancy <3 months
• Comorbidity/acute condition contraindicating exercise practice

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Europea de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universidad Europea de Madrid

Villaviciosa de Odón, Spain, Spain

Site Status: RECRUITING

UEM

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Alejandro Lucia

Role: CONTACT

alejandro.lucia@universidadeuropea.es

+34661393101

Facility Contacts

Role: primary

+34661393101

Other Identifiers

Universidad Europea de Madrid

Identifier Type: -

Identifier Source: org_study_id