Ignite Creation Date:
2024-05-06 @ 6:04 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05539794
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2022-04-18
Brief Title:
Exercise and Lifestyle in Adolescent Cancer HEALTHYADOL
Sponsor:
Universidad Europea de Madrid
Organization:
Universidad Europea de Madrid
Study Overview
Official Title:
Exercise and Lifestyle Intervention for Patients With Adolescent Cancer a Randomised Controlled Trial HEALTHY ADOL
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEALTHYADOL
Brief 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 tumoursintense 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 malefemale 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 KarnofskyEastern Cooperative Oncology Group scale score 502 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 tumoursintense 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 malefemale 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 KarnofskyEastern Cooperative Oncology Group scale score 502 to understand Spanish language and to provide written informed consent The investigators will recruit 136 participants and conduct a randomised controlled trial 11 ratio randomisation with a block on gender and tumour type leukaemiaslymphomas 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 sessionsweek 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 daysweek Health counselling will include a psychological intervention 1 sessionweek based on motivational interviewing techniques guidance by a nutritionist 2 sessionsmonth and support sessions 1month 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 tissuelean mass bone mineral contentdensity 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
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 tumoursintense 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 malefemale 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 KarnofskyEastern Cooperative Oncology Group scale score 502 to understand Spanish language and to provide written informed consent The investigators will recruit 136 participants and conduct a randomised controlled trial 11 ratio randomisation with a block on gender and tumour type leukaemiaslymphomas 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 sessionsweek 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 daysweek Health counselling will include a psychological intervention 1 sessionweek based on motivational interviewing techniques guidance by a nutritionist 2 sessionsmonth and support sessions 1month 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 tissuelean mass bone mineral contentdensity 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None