Exercise and Lifestyle in Adolescent Cancer (HEALTHYADOL) (HEALTHYADOL)

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).

Study Overview

• Status: Recruiting
• Conditions: Adolescent Cancer
• Intervention / Treatment: Behavioral: lifestyle and physical exercise

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).

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alejandro Lucia; Phone Number: +34661393101; Email: alejandro.lucia@universidadeuropea.es

Study Locations

• Spain
  • Madrid, Spain
    • Recruiting
    • UEM
  • Villaviciosa de Odón, Spain, 28670
    • Recruiting
    • Universidad Europea de Madrid
    • Contact: Phone Number: +34661393101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard care
Experimental: Intervention; The intervention group will follow a physical exercise and lifestyle counselling program.	Behavioral: lifestyle and physical exercise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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)
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)]
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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)]
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)]
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)]
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)]
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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)
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
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)
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)
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)
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
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)
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
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)
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Change in gut microbiome (alpha-diversity) from baseline to end of treatment	α-diversity	Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment)
Change in gut microbiome (alpha-diversity) from baseline to follow-up	α-diversity	Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up)
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)
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)
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)
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)
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
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: cancer; lifestyle; cardiac function
• Other Study ID Numbers: Universidad Europea de Madrid

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As per Spanish regulations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No