Adolescent Cancer Clinical Trial
— HEALTHYADOLOfficial title:
Exercise and Lifestyle Intervention for Patients With Adolescent Cancer: a Randomised Controlled Trial (HEALTHY ADOL)
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).
| Status | Recruiting |
| Enrollment | 136 |
| Est. completion date | March 31, 2026 |
| Est. primary completion date | December 31, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years to 19 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Spain | UEM | Madrid | |
| Spain | Universidad Europea de Madrid | Villaviciosa de Odón |
| Lead Sponsor | Collaborator |
|---|---|
| Universidad Europea de Madrid |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | |
| Primary | Change in left-ventricular (LV) function (LV ejection fraction) from baseline to follow-up | Echocardiography-determined LV ejection fraction (unit = %) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Primary | Change in left-ventricular (LV) function (LV fractional shortening) from baseline to follow-up | 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)] | |
| Primary | Change in left-ventricular (LV) function (LV fractional shortening) from baseline to follow-up | Echocardiography-determined LV fractional shortening (unit = %) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)] | |
| Secondary | Change in resting 'clinic' arterial blood pressure from baseline to end of treatment | Arterial blood pressure (BP) (ausculatory method) (units = mmHg) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis | |
| Secondary | Change in resting 'clinic' arterial blood pressure from baseline to follow-up | Arterial blood pressure (BP) (ausculatory method) (units = mmHg) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in serum lipid profile (cholesterol) from baseline to end of treatment | Total/HDL/LDL-cholesterol will be quantified with an automated chemistry analyser (units = mg/dL). | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis)] | |
| Secondary | Change in serum lipid profile (cholesterol) from baseline to follow-up | Total/HDL/LDL-cholesterol will be quantified with an automated chemistry analyser (units = mg/dL). | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)] | |
| Secondary | Change in serum lipid profile (triglycerides) from baseline to end of treatment | Tiglycerides will be quantified with an automated chemistry analyser (units = mg/dL). | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis)] | |
| Secondary | Change in serum lipid profile (triglycerides) from baseline to follow-up | Tiglycerides will be quantified with an automated chemistry analyser (units = mg/dL). | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)] | |
| Secondary | Change in adiposity index from baseline to end of treatment | Waist-to-hip ratio (no units) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in adiposity index from baseline to follow-up | Waist-to-hip ratio (no units) | Assessed at two time points: (1) at baseline (diagnosis); (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in DXA measures of lean mass from baseline to end of treatment | DXA-determined total lean mass (grams) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in DXA measures of lean mass from baseline to follow-up | DXA-determined total lean and fat mass (grams) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in DXA measures of fat mass from baseline to end of tratment | DXA-determined total fat mass (grams) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in DXA measures of fat mass from baseline to follow-up | DXA-determined total fat mass (grams) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in DXA measure of bone health from baseline to end of treatment | DXA-determined bone mineral density (unit = g/m2) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in DXA measure of bone health from baseline to follow-up | DXA-determined bone mineral density (unit = g/m2) | Assessed at two time points: (1) at baseline (diagnosis); and 3 months after the end of treatment (follow-up) | |
| Secondary | Change in physical activity (PA) from baseline to end of treatment | PA levels (moderate/vigorous PA) determined using triaxial accelerometry (units =minutes/week) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in physical activity (PA) from baseline to follow-up | PA levels (moderate/vigorous PA) determined using triaxial accelerometry (units = minutes/week) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in total energy intake from baseline to end of treatment. | 3-day 24 h-dietary recalls to record the participants' energy intake by either themselves or parents/caregivers.
3-day, 24 h-dietary recalls will be used to record the participants' energy intake by either themselves or parents/caregivers. The investigators will provide participants with instructions on how to obtain a correct food record. Dietary recall data will be analysed using Dietsource 3.0 (Novartis) to determine total energy intake (kcal) |
Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in total energy intake from baseline to follow-up | 3-day 24 h-dietary recalls to record the participants' energy intake by either themselves or parents/caregivers.
3-day, 24 h-dietary recalls will be used to record the participants' energy intake by either themselves or parents/caregivers. The investigators will provide participants with instructions on how to obtain a correct food record. Dietary recall data will be analysed using Dietsource 3.0 (Novartis) to determine total energy intake (kcal) |
Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in energy intake by sustrate from baseline to end of treatment | 3-day 24 h-dietary recalls to record the participants' energy intake by either themselves or parents/caregivers.
3-day, 24 h-dietary recalls will be used to record the participants' energy intake by either themselves or parents/caregivers. The participants will provide participants with instructions on how to obtain a correct food record. Dietary recall data will be analysed using Dietsource 3.0 (Novartis) to determine protein, fat, carbohydrate, and fiber intake (g/day) |
Assessed at two time points: (1) at baseline (diagnosis); and (2) (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in energy intake by sustrate from baseline to follow-up | 3-day 24 h-dietary recalls to record the participants' energy intake by either themselves or parents/caregivers.
3-day, 24 h-dietary recalls will be used to record the participants' energy intake by either themselves or parents/caregivers. The participants will provide participants with instructions on how to obtain a correct food record. Dietary recall data will be analysed using Dietsource 3.0 (Novartis) to determine protein, fat, carbohydrate, and fiber intake (g/day) |
Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in cardiorespiratory fitness (VO2peak) from baseline to end of treatment | VO2peak will be determined with 'breath-by breath' analysis of expired gases on a metabolic cart using a ramp-like treadmill--or arm-crank ergometer--test (units = mL/kg/min) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in cardiorespiratory fitness (VO2peak) from baseline to follow-up | VO2peak will be determined with 'breath-by breath' analysis of expired gases on a metabolic cart using a ramp-like treadmill--or arm-crank ergometer--test (units = mL/kg/min) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in muscle strength from baseline to end of treatment | The 5-repetition maximum (commonly abbreviated as 5RM), which is the maximum strength capacity to perform 5 repetitions until momentary muscular exhaustion, will be measured for leg press and bench press (units = kg). | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in muscle strength from baseline to follow-up | The 5-repetition maximum (commonly abbreviated as 5RM), which is the maximum strength capacity to perform 5 repetitions until momentary muscular exhaustion, will be measured for leg press and bench press (units = kg). | Assessed at two time points: (1) at baseline (diagnosis);and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in inspiratory muscle strength (PImax) from baseline to end of treatment | PImax (units = cmH20) will be determined using a mouth pressure meter with the best result from 3 attempts (interspersed with rest periods of =1 min-duration) taken. | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in inspiratory muscle strength (PImax) from baseline to follow-up | PImax (units = cmH20) will be determined using a mouth pressure meter with the best result from 3 attempts (interspersed with rest periods of =1 min-duration) taken. | Assessed at three time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in psychological status (quality of life) from baseline to end of treatment | Health-related QoL (HRQoL) (Paediatric Quality of Life Inventory [PedsQL] 3.0 Cancer Module, designed to measure paediatric/adolescent cancer specific HRQoL) (0 to 100 scale, with higher scores indicating better HRQoL) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in psychological status (quality of life) from baseline to follow-up | Health-related QoL (HRQoL) (Paediatric Quality of Life Inventory [abbreviated as PedsQL] 3.0 Cancer Module, designed to measure paediatric/adolescent cancer specific HRQoL) (0 to 100 scale, with higher scores indicating better HRQoL) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in psychological status (fatigue) from baseline to end of treatment | Cancer-related fatigue (Paediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale) (0 to 100 score, higher scores meaning higher fatigue) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in psychological status (fatigue) from baseline to follow-up | Cancer-related fatigue (Paediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale) (0 to 100 score, higher scores meaning higher fatigue | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in psychological status (stress) from baseline to end of treatment | Stress coping (General form of the Adolescent Coping Scale) (0 to 20 scale, with higher scores indicating higher resilience to stress) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in psychological status (stress) from baseline to follow-ip | Stress coping (General form of the Adolescent Coping Scale) (0 to 20 scale, with higher scores indicating higher resilience to stress) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in psychological status (anxiety) from baseline to end of treatment | Anxiety (six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory [abbbreviated as STAI]) (0 to 100 score, with higher scores reflecting higher anxiety levels) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in psychological status (anxiety) from baseline to follow-up | Anxiety (six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory [abbreviated as STAI]) (0 to 100 score, with higher scores reflecting higher anxiety levels) | Assessed at two time points: (1) at baseline (diagnosis); (2) 14 to 28 weeks after diagnosis (i.e., end of treatment); and (3) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in psychological status (depression) from baseline to end of treatment | Depression (Child Depression Scale) (0 to 52 scale, with higher scores reflecting more depression) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis | |
| Secondary | Change in psychological status (depression) from baseline to follow-up | Depression (Child Depression Scale) (0 to 52 scale, with higher scores reflecting more depression) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in clinical variables (survival) from baseline to end of treatment | Survival (numebr of days from diagnosis to the end of the study or death) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis | |
| Secondary | Change in clinical variables (survival) from baseline to follow-up | Survival (number of days from diagnosis to the end of the study or death) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Changes in clinical variables (treatment tolerability) from baseline to end of treatment | Treatment tolerability (number of days of treatment interruption/delay | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Changes in clinical variables (treatment tolerability) from baseline to follow-up | Treatment tolerability (number of days of treatment interruption/delay | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in clinical variables (days of hospitalization) from baseline to end of treatment | Total hospitalisation length (number of days) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis | |
| Secondary | Change in clinical variables (days of hospitalization) from baseline to follow-up | Total hospitalisation length (number of days) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in clinical variables (global score of Common Toxicity Criteria for Adverse Events [CTCAE]) from baseline to end of treatment | Common Toxicity Criteria for Adverse Events [CTCAE, global score, 1 (low toxicity) to 5 (highest]) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis | |
| Secondary | Change in clinical variables (global score of Common Toxicity Criteria for Adverse Events [CTCAE]) from baseline to follow-up | Common Toxicity Criteria for Adverse Events [CTCAE, global score, 1 (low toxicity) to 5 (highest]) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in metabolic markers (glucose) from baseline to end of treatment | Serum fasting glycaemia (mg/dL) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis | |
| Secondary | Change in metabolic markers (glucose) from baseline to follow-up | Serum fasting glycaemia (mg/dL) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Metabolic markers (insulin) from baseline to end of treatment | Serum fasting insulinaemia (pmol/L) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Metabolic markers (insulin) from baseline to follow-up | Serum fasting insulinaemia (pmol/L) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in metabolic markers (HOMA-IR) from baseline to end of treatment | Homeostasis model assessment-insulin resistance index (HOMA-IR) (molar units) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in metabolic markers (HOMA-IR) from baseline to follow-up | Homeostasis model assessment-insulin resistance index (HOMA-IR) (molar units) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in inflammation (C-reactive protein) from baseline to end of treatment | C-reactive protein (mg/L) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in metabolic markers (C-reactive protein) from baseline to follow-up | C-reactive protein (mg/L) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in inflammatory markers (cytokines/chemokines) from baseline to end of treatment | Panel of 21 cytokines/chemokines measured in serum using Luminex® (all assessed in the same units, micrograms/dL) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in inflammatory markers (cytokines/chemokines) from baseline to follow-up | Panel of 21 cytokines/chemokines measured in serum using Luminex® (all assessed in the same units, micrograms/dL) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (i.e., follow-up) | |
| Secondary | Change in plasma proteome from baseline to end of treatment | The investigators will use liquid chromatography coupled to tandem-mass spectrometry (LC-MS/MS) to measure levels in blood of thousands of proteins | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in plasma proteome from baseline to follow-up | The investigators will use liquid chromatography coupled to tandem-mass spectrometry (LC-MS/MS) to measure levels in blood of thousands of proteins | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in gut microbiome (alpha-diversity) from baseline to end of treatment | a-diversity | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in gut microbiome (alpha-diversity) from baseline to follow-up | a-diversity | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in gut microbiome (beta-diversity) from baseline to end of treatment | beta-diversity | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in gut microbiome (beta-diversity) from baseline to follow-up | Beta-diversity | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in gut microbiome (specific bacteria) from baseline to end of treatment | Changes in bacteria abundance | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in gut microbiome (specific bacteria) from baseline to follow-up | Changes in bacteria abundance | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in Immune phenotype (lymphocyte subpopulations) from baseline to end of treatment | Lymphocyte subpopulations (%) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis | |
| Secondary | Change in Immune phenotype (lymphocyte subpopulations) from baseline to follow-up | Lymphocyte subpopulations (%) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in Immune phenotype (natural killer (NK) cells) from baseline to end of treatment | NK cell subsets (%) | Assessed at two time points: (1) at baseline (diagnosis); (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in Immune phenotype (NK cells) from baseline to follow-up | NK cell subsets (%) | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) | |
| Secondary | Change in Immune function from baseline to end of treatment | NK cell receptors | Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) | |
| Secondary | Change in immune function from baseline to follow-up | NK cell receptors | Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) |
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