Exercise and Lifestyle in Adolescent Cancer (HEALTHYADOL)
- Conditions
- Adolescent Cancer
- Interventions
- Behavioral: lifestyle and physical exercise
- Registration Number
- NCT05539794
- Lead Sponsor
- Universidad Europea de Madrid
- 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 \[solid tumours\]/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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 136
- 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.
- Life expectancy <3 months
- Comorbidity/acute condition contraindicating exercise practice
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention lifestyle and physical exercise The intervention group will follow a physical exercise and lifestyle counselling program.
- Primary Outcome Measures
Name Time Method Change in left-ventricular (LV) function.(LV ejection fraction) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) Echocardiography-determined LV ejection fraction (unit = %)
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)] Echocardiography-determined LV fractional shortening (unit = %)
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) Echocardiography-determined LV ejection fraction (unit = %)
- Secondary Outcome Measures
Name Time Method Change in DXA measures of lean mass 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) DXA-determined total lean and fat mass (grams)
Change in resting '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 Arterial blood pressure (BP) (ausculatory method) (units = mmHg)
Change in resting '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) Arterial blood pressure (BP) (ausculatory method) (units = mmHg)
Change in serum lipid profile (cholesterol) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis)] Total/HDL/LDL-cholesterol will be quantified with an automated chemistry analyser (units = mg/dL).
Change in serum lipid profile (cholesterol) 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)] Total/HDL/LDL-cholesterol will be quantified with an automated chemistry analyser (units = mg/dL).
Change in adiposity index from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) Waist-to-hip ratio (no units)
Change in serum lipid profile (triglycerides) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis)] Tiglycerides will be quantified with an automated chemistry analyser (units = mg/dL).
Change in serum lipid profile (triglycerides) 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)] Tiglycerides will be quantified with an automated chemistry analyser (units = mg/dL).
Change in DXA measures of lean mass from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) DXA-determined total lean mass (grams)
Change in DXA measures of fat mass 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) DXA-determined total fat mass (grams)
Change in DXA measure of bone health from baseline to follow-up Assessed at two time points: (1) at baseline (diagnosis); and 3 months after the end of treatment (follow-up) DXA-determined bone mineral density (unit = g/m2)
Change in physical activity (PA) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) PA levels (moderate/vigorous PA) determined using triaxial accelerometry (units =minutes/week)
Change in cardiorespiratory fitness (VO2peak) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., 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)
Change in cardiorespiratory fitness (VO2peak) 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) 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)
Change in inspiratory muscle strength (PImax) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., 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.
Change in psychological status (quality of life) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., 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)
Change in clinical variables (survival) 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) Survival (number of days from diagnosis to the end of the study or death)
Changes in clinical variables (treatment tolerability) 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) Treatment tolerability (number of days of treatment interruption/delay
Change in adiposity index from baseline to follow-up Assessed at two time points: (1) at baseline (diagnosis); (2) 3 months after the end of treatment (follow-up) Waist-to-hip ratio (no units)
Change in DXA measures of fat mass from baseline to end of tratment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) DXA-determined total fat mass (grams)
Change in DXA measure of bone health from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) DXA-determined bone mineral density (unit = g/m2)
Change in physical activity (PA) 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) PA levels (moderate/vigorous PA) determined using triaxial accelerometry (units = minutes/week)
Change in muscle strength 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) 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).
Change in inspiratory muscle strength (PImax) from baseline to follow-up Assessed at three time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (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.
Change in psychological status (fatigue) 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) Cancer-related fatigue (Paediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale) (0 to 100 score, higher scores meaning higher fatigue
Change in psychological status (anxiety) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., 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)
Change in psychological status (depression) 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) Depression (Child Depression Scale) (0 to 52 scale, with higher scores reflecting more depression)
Change in clinical variables (survival) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis Survival (numebr of days from diagnosis to the end of the study or death)
Changes in clinical variables (treatment tolerability) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) Treatment tolerability (number of days of treatment interruption/delay
Change in metabolic markers (glucose) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis Serum fasting glycaemia (mg/dL)
Metabolic markers (insulin) 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) Serum fasting insulinaemia (pmol/L)
Change in metabolic markers (HOMA-IR) 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) Homeostasis model assessment-insulin resistance index (HOMA-IR) (molar units)
Change in inflammatory markers (cytokines/chemokines) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) Panel of 21 cytokines/chemokines measured in serum using Luminex® (all assessed in the same units, micrograms/dL)
Change in total energy intake from baseline to end of treatment. Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., 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)Change in total energy intake from baseline to follow-up Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., 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)Change in energy intake by sustrate from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) (2) 14 to 28 weeks after diagnosis (i.e., 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)Change in energy intake by sustrate 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) 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)Change in muscle strength from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., 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).
Change in psychological status (quality of life) 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) 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)
Change in psychological status (stress) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) Stress coping (General form of the Adolescent Coping Scale) (0 to 20 scale, with higher scores indicating higher resilience to stress)
Change in psychological status (stress) from baseline to follow-ip Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (follow-up) Stress coping (General form of the Adolescent Coping Scale) (0 to 20 scale, with higher scores indicating higher resilience to stress)
Change in metabolic markers (glucose) 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) Serum fasting glycaemia (mg/dL)
Metabolic markers (insulin) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) Serum fasting insulinaemia (pmol/L)
Change in metabolic markers (HOMA-IR) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) Homeostasis model assessment-insulin resistance index (HOMA-IR) (molar units)
Change in inflammation (C-reactive protein) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) C-reactive protein (mg/L)
Change in psychological status (fatigue) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) Cancer-related fatigue (Paediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale) (0 to 100 score, higher scores meaning higher fatigue)
Change in psychological status (anxiety) from baseline to follow-up 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) 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)
Change in psychological status (depression) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis Depression (Child Depression Scale) (0 to 52 scale, with higher scores reflecting more depression)
Change in clinical variables (global score of Common Toxicity Criteria for Adverse Events [CTCAE]) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis Common Toxicity Criteria for Adverse Events \[CTCAE, global score, 1 (low toxicity) to 5 (highest\])
Change in plasma proteome from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., 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
Change in clinical variables (days of hospitalization) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis Total hospitalisation length (number of days)
Change in clinical variables (days of hospitalization) 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) Total hospitalisation length (number of days)
Change in clinical variables (global score of Common Toxicity Criteria for Adverse Events [CTCAE]) 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) Common Toxicity Criteria for Adverse Events \[CTCAE, global score, 1 (low toxicity) to 5 (highest\])
Change in metabolic markers (C-reactive protein) 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) C-reactive protein (mg/L)
Change in inflammatory markers (cytokines/chemokines) from baseline to follow-up Assessed at two time points: (1) at baseline (diagnosis); and (2) 3 months after the end of treatment (i.e., follow-up) Panel of 21 cytokines/chemokines measured in serum using Luminex® (all assessed in the same units, micrograms/dL)
Change in plasma proteome 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) The investigators will use liquid chromatography coupled to tandem-mass spectrometry (LC-MS/MS) to measure levels in blood of thousands of proteins
Change in gut microbiome (alpha-diversity) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) α-diversity
Change in gut microbiome (specific bacteria) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) Changes in bacteria abundance
Change in gut microbiome (specific bacteria) 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) Changes in bacteria abundance
Change in Immune phenotype (lymphocyte subpopulations) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis Lymphocyte subpopulations (%)
Change in Immune phenotype (lymphocyte subpopulations) 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) Lymphocyte subpopulations (%)
Change in Immune phenotype (natural killer (NK) cells) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) NK cell subsets (%)
Change in Immune function from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) NK cell receptors
Change in immune function 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) NK cell receptors
Change in gut microbiome (alpha-diversity) 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) α-diversity
Change in gut microbiome (beta-diversity) from baseline to end of treatment Assessed at two time points: (1) at baseline (diagnosis); and (2) 14 to 28 weeks after diagnosis (i.e., end of treatment) beta-diversity
Change in gut microbiome (beta-diversity) 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) Beta-diversity
Change in Immune phenotype (NK cells) 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) NK cell subsets (%)
Trial Locations
- Locations (2)
Universidad Europea de Madrid
🇪🇸Villaviciosa de Odón, Spain
UEM
🇪🇸Madrid, Spain