Trial Title:
Exercise and Lifestyle in Adolescent Cancer (HEALTHYADOL)
NCT ID:
NCT05539794
Condition:
Adolescent Cancer
Conditions: Keywords:
cancer
lifestyle
cardiac function
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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 gender and main tumour type [leukaemias/solid
tumours])
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Masking description:
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, psycho-oncologists and nutritionists) involved in the
different intervention (physical exercise and health counselling) 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.
Intervention:
Intervention type:
Behavioral
Intervention name:
lifestyle and physical exercise
Description:
the intervention group will follow a physical exercise and health counselling
intervention--see below.
The exercise program will be performed in the hospital gymnasium (3 supervised
sessions/week of aerobic and muscle strength exercises) or in the patients' room (during
phases of treatment-induced immunodepression, where isolation is needed to prevent
infections). It will also include specific training of the respiratory ('inspiratory')
muscles (e.g., diaphragm) on 5 days/week. The counselling program will include
psychological (once weekly), nutritional (twice monthly), support (with survivors of
adolescent cancer, twice/month) and educational (for relatives/caregivers, once monthly)
sessions.
Arm group label:
Intervention
Summary:
The investigators will study the effects of an inhospital exercise intervention combined
with lifestyle--including diet--counselling along the duration of treatment (neoadjuvant
[solid tumours]/intense chemotherapy [leukemias], expected median duration 5-6 months) on
several health-related variables. Participants will be recruited from 3 hospitals in
Madrid (Spain). Inclusion criteria: male/female aged 12-19 years, newly diagnosed with 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. In addition to usual care, the control group will be
informed of the benefits of a healthy lifestyle. The intervention group will follow a
physical exercise and lifestyle counselling program. The exercise intervention will be
performed in the hospital gymnasium, except for neutropenic phases--during which time
sessions will be performed in the patients' ward--and will also include inspiratory
muscle training). Health counselling will include a psychological intervention based on
motivational interviewing techniques, guidance by a nutritionist, and support sessions
with survivors who will share their experiences with the study participants. 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 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, stress coping, anxiety,
depression, clinical variables, and potential biological underpinnings of exercise
multisystemic benefits (metabolic and inflammatory [cytokine panel] 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 an inhospital 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 an inhospital exercise
intervention combined with lifestyle--including diet--counselling along the duration of
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 3 hospitals in Madrid (Spain).
Inclusion criteria: male/female aged 12-19 years, newly diagnosed with 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 control group will be informed of the benefits of a
healthy lifestyle. 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 inspiratory muscle training (5 days/week). Health counselling will include a
psychological intervention (1 session/week) based on motivational interviewing
techniques, guidance by a nutritionist (2 sessions/month), and support sessions (1/month)
with survivors (≥5-year survivorship) who will share their experiences with the study
participants. The following outcomes will be assessed at baseline (diagnosis), end of
treatment, and at 3-month follow-up in all participants: echocardiographydetermined left
ventricular function (primary outcome); and blood pressure, blood lipids, dual-energy
X-ray absorptiometry-determined body composition (fat [including visceral adipose
tissue]/lean mass, bone mineral content/density), accelerometry-determined physical
activity, dietary recall determined energy intake, cardiorespiratory fitness, muscle
strength, functional mobility, health-related quality of life, cancer-related fatigue,
stress coping, anxiety, depression, clinical variables (survival, treatment tolerability,
hospitalisation length, infections), and potential biological underpinnings of exercise
multisystemic benefits (metabolic [glucose homeostasis indicators, high-sensitivity
C-reactive protein] and inflammatory [cytokine panel] markers, plasma proteome, gut
microbiome, and immune function [lymphocyte subpopulations, natural killer cell
cytotoxicity]) (secondary outcomes).
Criteria for 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
Gender:
All
Minimum age:
12 Years
Maximum age:
19 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
UEM
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
Universidad Europea de Madrid
Address:
City:
Villaviciosa de Odón
Zip:
28670
Country:
Spain
Status:
Recruiting
Contact:
Phone:
+34661393101
Start date:
September 15, 2022
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Universidad Europea de Madrid
Agency class:
Other
Source:
Universidad Europea de Madrid
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05539794
