Exercise in Adolescents With Cancer

NCT05539794 | Recruiting

• 1 other identifier: Universidad Europea de Madrid
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

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).

Conditions

Adolescent Cancer

Keywords

cancer; lifestyle; cardiac function

Outcome Measures

Primary Outcomes (3)

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

  Echocardiography-determined LV ejection fraction (unit = %)

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

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

  Echocardiography-determined LV fractional shortening (unit = %)

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

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

  Echocardiography-determined GLS (%)

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

Secondary Outcomes (115)

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

  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

  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)

  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

  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

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

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will follow a supervised physical exercise program.

Behavioral: Physical exercise

Control

NO INTERVENTION

Standard care

Interventions

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.

Intervention

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (2)

Universidad Europea de Madrid

Villaviciosa de Odón, Spain, 28670, Spain

RECRUITING

UEM

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Alejandro Lucia

CONTACT

+34661393101; alejandro.lucia@universidadeuropea.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessment staff will be blinded to participant randomisation assignment. Yet, because of the nature of the study, it will not be possible to conceal the group assignment from the staff (i.e., fitness specialists) involved in the intervention (physical exercise) sessions. Participants will be explicitly informed on the group to which they will be assigned as well as on the study hypotheses and will be reminded not to discuss their randomisation assignments with assessment staff and/or other patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will apply a two-arm RCT design, following the Consolidated Standards of Reporting Trials recommendations (1:1 randomisation ratio using a computer-generated random allocation sequence with a block on sex and main tumour type \[leukaemias/solid tumours\]).

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: September 14, 2022
• Study Start: April 15, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)