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Completed

NCT Number: NCT05615883

Effects of Acute and Chronic Exercise on Myeloid-Derived Suppressor Cells in Melanoma Patients

This study is designed to investigate the effects of ketogenic milieu induced by acute exercise as well as the effects of recurrent exercise bouts on functional status and the accumulation in peripheral blood of MDSCs and the consequent balance on antitumor immunity in melanoma patients.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy, 20033

About this study

The screening period starts once a patient has provided written informed consent to participate in the study and ends on the day of exercise initiation. Screening assessments have to be done within 28 days prior to exercise initiation. The informed consent will adhere to IRB/ERC requirements, applicable laws and regulations. After the sign of an informed consensus, patients will be assigned to a specific exercise program. The first series of patients will be assigned to the Acute Exercise Program (AEP group), the second series to the Chronic Exercise Program (CEP group). The protocol will be implemented in the time between diagnosis and surgical intervention without any delay in the therapeutic pathway.

Basal evaluation: patient's life style will be investigated using the short version of Physical Activity Questionnaire (Italian version) and MeDiet questionnaire. Age, weight and eight will be registered for all patients. The Lean Body Mass will be measured by Dual Energy X-ray Absorptiometry (DEXA). A cardiorespiratory test will be performed to calculate an appropriate exercise intensity and subsequently the Six Minutes WalkingTest and the Comfortable Walking Speed test will be run before exercise protocol. In the CEP group the DEXA and the walking tests will be repeated after the end of exercise program.

Exercise prescription: the physical exercise consists in walking at a brisk pace. In order to produce a constant metabolic stress in patients with different aerobic power, walking intensity will be prescribed in accordance with the method of the Heart Rate Reserve (HRR), ie difference between resting heart rate (HR-resting) and the heart rate corresponding to muscle's maximal oxygen uptake (HR-max). This prescribing method is based on the linear relationship between heart rate reserve and muscle workload calculated as a percentage of the difference between resting and maximum muscle oxygen consumption (VO2R%). The training intensity will be set to the 30% HRR, the lowest intensity that produces a training effect. To minimize the impact of the research protocol on the patient's therapeutic path, the investigators refrain from the execution of a Cardio Pulmonary Exercise Test and therefore opted for calculating the HR-max using the ACSM formula. Given the entry criteria of this study the investigators believe this choice will minimally affect the exercise-dose prescription and study results.

Acute Exercise Protocol (AEP): The acute program consists in a single walking session on a treadmill lasting 80 minutes. The exercise session will begin with a 10-minute warm-up at the patient's self selected comfortable speed. On the ending of warm up, treadmill speed will be increased until reaching target HRR zone. Then the treadmill speed will be maintained stable throughout the exercise session. Cardiac workload will be monitored by a Sport-watch (Garmin Forerunner 35) and the walking biomechanics by a foot sensor (Garmin Running Dynamic Pod Sensore).

Chronic Exercise Protocol (CEP): The chronic program consists in a walking session on a treadmill lasting 80 minutes (depending on the AEP results), repeated three time a week for three weeks. The walking intensity will be defined during a treadmill test performed before the beginning of the exercise program. Each exercise session will begin with a 10-minute warm-up at the patient's self selected comfortable speed. On the ending of warm up, patients will increase treadmill speed until reaching target HRR zone. Then the treadmill speed will be maintained stable throughout the exercise session. The first training session will be organized in hospital with supervision of research staff. Cardiac workload will be monitored by a Sport-watch(Garmin Forerunner 35) and walking biomechanics by a foot sensor (Garmin Running Dynamic Pod Sensore).

Diet intervention: Modifications occurring during AEP strictly depend on the baseline metabolic conditions. For this reason, patients must remain fasting for 4 hours before the workout and avoid glucose rich foodies for 120 minutes after the end of exercise session in CEP group. During the exercise session patients will have free access to water only. All patients will complete a food diary during the study period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 18 to 65 years at the time of recruitment
  • Histologically confirmed diagnosis of primary melanoma
  • Patients who are candidate to curative surgery for primary melanoma, skin radicalization or sentinel node biopsy.
  • American Society of Anaesthesiologists (ASA) status I
  • Willingness and ability to comply with the protocol, the scheduled visits, treatment plans, laboratory tests and other procedures.
  • Understanding and signature of the informed consent
  • Female patients of childbearing potential must agree to sexual abstinence or to use highly effective method of contraception throughout the study (for CEP patients)

Exclusion criteria

  • American Society of Anaesthesiologists (ASA) status > I
  • Pregnancy or lactation
  • Known infection from HIV virus
  • Regular physical exercise (more than 1 exercise workout of moderate to intense exercise activity per week)
  • Any physical or mental conditions interfering with the ability to perform exercise or to complete the testing procedures.

Treatment and study plan

AEP Group Walking Sessions

Other

The AEP Program consists in a single walking session on a treadmill lasting 80 minutes

CEP Group Walking Sessions

Other

The chronic program consists in a walking session on a treadmill lasting 80 minutes (depending on the AEP results), repeated three time a week for three weeks.

Primary outcomes

  1. Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)

    Time frame: AEP group: before exercise session.

    Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.

  2. Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)

    Time frame: AEP group: after 40 minutes of exercise session.

    Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.

  3. Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)

    Time frame: AEP group: after 80 minutes of exercise session.

    Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.

  4. Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)

    Time frame: AEP group: at 24 post-exercise.

    Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.

  5. Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)

    Time frame: AEP group: at 72 hours post-exercise.

    Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.

  6. Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)

    Time frame: CEP group: before exercise program.

    Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.

  7. Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)

    Time frame: CEP group: after one week of exercise program.

    Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.

  8. Quantification of the immune cell subsets (to determine if occur the re-setting antitumor immunity by short-term physical exercise)

    Time frame: CEP group: up to two weeks of exercise program.

    Immune cells will be analyzed for frequency and function by 10-color flow cytometry to test the reciprocal balance of protumor vs antitumor immune subsets. The analysis, based in the application of multiple panels of different antibodies, will be performed on peripheral blood mononuclear cells (PBMC) isolated from peripheral blood.

  9. Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)

    Time frame: AEP group: before exercise.

    CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).

  10. Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)

    Time frame: AEP group: after 40 minutes of exercise session

    CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).

  11. Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)

    Time frame: AEP group: after 80 minutes of exercise session.

    CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).

  12. Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)

    Time frame: AEP group: at 24 post-exercise.

    CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).

  13. Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)

    Time frame: AEP group: at 72 hours post-exercise.

    CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).

  14. Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)

    Time frame: CEP group: before exercise program.

    CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).

  15. Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)

    Time frame: CEP group: after one week of exercise program.

    CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).

  16. Transcriptional Immune cell profiling (to determine if occur the re-setting antitumor immunity by short-term physical exercise)

    Time frame: CEP group: up to two weeks of exercise program.

    CD14+, CD15+ and total immune cells will be immunosorted directly from whole blood (3 ml) and frozen for the targeted expression profiling of signaling pathways and functional patterns (Nanostring or customized PCR cards).

  17. Analysis of the "systemic metabolic milieu"_AEPMet before

    Time frame: AEP group: before exercise.

    In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters

  18. Analysis of the "systemic metabolic milieu"_AEPHor before

    Time frame: AEP group: before exercise.

    In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters

  19. Analysis of the "systemic metabolic milieu"_AEPInf before

    Time frame: AEP group: before exercise.

    In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters

  20. Analysis of the "systemic metabolic milieu"_AEPLip before

    Time frame: AEP group: before exercise.

    We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes

  21. Analysis of the "systemic metabolic milieu"_AEPcounts before

    Time frame: AEP group: before exercise.

    Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.

  22. Analysis of the "systemic metabolic milieu"_AEPMet 40

    Time frame: AEP group: after 40 minutes of exercise session.

    In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters

  23. Analysis of the "systemic metabolic milieu"_AEPHor 40

    Time frame: AEP group: after 40 minutes of exercise session.

    In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters

  24. Analysis of the "systemic metabolic milieu"_AEPInf 40

    Time frame: AEP group: after 40 minutes of exercise session.

    In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters

  25. Analysis of the "systemic metabolic milieu"_AEPLip 40

    Time frame: AEP group: after 40 minutes of exercise session.

    We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes

  26. Analysis of the "systemic metabolic milieu"_AEPcounts 40

    Time frame: AEP group: after 40 minutes of exercise session.

    Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.

  27. Analysis of the "systemic metabolic milieu"_AEPMet 80

    Time frame: AEP group: after 80 minutes of exercise session.

    In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters

  28. Analysis of the "systemic metabolic milieu"_AEPHor 80

    Time frame: AEP group: after 80 minutes of exercise session.

    In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters

  29. Analysis of the "systemic metabolic milieu"_AEPInf 80

    Time frame: AEP group: after 80 minutes of exercise session.

    In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters

  30. Analysis of the "systemic metabolic milieu"_AEPLip 80

    Time frame: AEP group: after 80 minutes of exercise session.

    We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes

  31. Analysis of the "systemic metabolic milieu"_AEPcounts 80

    Time frame: AEP group: after 80 minutes of exercise session.

    Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.

  32. Analysis of the "systemic metabolic milieu"_AEPMet 24

    Time frame: AEP group: at 24 post-exercise.

    In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters

  33. Analysis of the "systemic metabolic milieu"_AEPHor 24

    Time frame: AEP group: at 24 post-exercise.

    In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters

  34. Analysis of the "systemic metabolic milieu"_AEPInf 24

    Time frame: AEP group: at 24 post-exercise.

    In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters

  35. Analysis of the "systemic metabolic milieu"_AEPLip 24

    Time frame: AEP group: at 24 post-exercise.

    We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes

  36. Analysis of the "systemic metabolic milieu"_AEPcounts 24

    Time frame: AEP group: at 24 post-exercise.

    Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.

  37. Analysis of the "systemic metabolic milieu"_AEPMet 72

    Time frame: AEP group: at 72 hours post-exercise.

    In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters

  38. Analysis of the "systemic metabolic milieu"_AEPHor 72

    Time frame: AEP group: at 72 hours post-exercise.

    In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters

  39. Analysis of the "systemic metabolic milieu"_AEPInf 72

    Time frame: AEP group: at 72 hours post-exercise.

    In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters

  40. Analysis of the "systemic metabolic milieu"_AEPLip 72

    Time frame: AEP group: at 72 hours post-exercise.

    We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes

  41. Analysis of the "systemic metabolic milieu"_AEPcounts 72

    Time frame: AEP group: at 72 hours post-exercise.

    Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.

  42. Analysis of the "systemic metabolic milieu"_CEPMet before

    Time frame: CEP group: before exercise program.

    In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters

  43. Analysis of the "systemic metabolic milieu"_CEPHor before

    Time frame: CEP group: before exercise program.

    In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters

  44. Analysis of the "systemic metabolic milieu"_CEPInf before

    Time frame: CEP group: before exercise program.

    In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters

  45. Analysis of the "systemic metabolic milieu"_CEPLip before

    Time frame: CEP group: before exercise program.

    We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes

  46. Analysis of the "systemic metabolic milieu"_CEP counts before

    Time frame: CEP group: before exercise program.

    Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.

  47. Analysis of the "systemic metabolic milieu"_CEPMet 1w

    Time frame: CEP group: after one week of exercise program.

    In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters

  48. Analysis of the "systemic metabolic milieu"_CEPHor 1w

    Time frame: CEP group: after one week of exercise program.

    In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters

  49. Analysis of the "systemic metabolic milieu"_CEPInf 1w

    Time frame: CEP group: after one week of exercise program.

    In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters

  50. Analysis of the "systemic metabolic milieu"_CEPLip 1w

    Time frame: CEP group: after one week of exercise program.

    We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes

  51. Analysis of the "systemic metabolic milieu"_CEPcounts 1w

    Time frame: CEP group: after one week of exercise program.

    Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.

  52. Analysis of the "systemic metabolic milieu"_CEPMet 2w

    Time frame: CEP group: up to two week of exercise program.

    In plasma we will quantify pH, Lactate, Ketone bodies, Free Fatty Acids, Glucose and Insulin serum levels that will be combined to report the metabolic parameters

  53. Analysis of the "systemic metabolic milieu"_CEPHor 2w

    Time frame: CEP group: up to two week of exercise program.

    In serum we will quantify ACTH, cortisol, epinephrine and norepinephrine concentrations that will be combined to report the hormonal parameters

  54. Analysis of the "systemic metabolic milieu"_CEPInf 2w

    Time frame: CEP group: up to two week of exercise program.

    In blood we will quantify IL-6, CRP, inflammatory cito/chemokines such as IL8, CCL2, IFN, IL10, IL1b, TNFa, TGFb that will be combined to report the inflammatory parameters

  55. Analysis of the "systemic metabolic milieu"_CEPLip 2w

    Time frame: CEP group: up to two week of exercise program.

    We will analyze the Lipidomics and amino acid profiles by laboratory test that will be combined to report the composition of cell membranes

  56. Analysis of the "systemic metabolic milieu"_CEPcounts 2w

    Time frame: CEP group: up to two week of exercise program.

    Whole blood cell counts will be also performed; this parameter is characterized by the absolute number as well as relative ratio.

  57. Analysis of the metabolic parameters by capillary sampling_AEPCap before

    Time frame: AEP group: before exercise session.

    Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).

  58. Analysis of the metabolic parameters by capillary sampling_AEPCap 40

    Time frame: AEP group: after 40 minutes of exercise session.

    Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).

  59. Analysis of the metabolic parameters by capillary sampling_AEPCap 80

    Time frame: AEP group: after 80 minutes of exercise session.

    Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).

  60. Analysis of the metabolic parameters by capillary sampling_AEPCap 24

    Time frame: AEP group: at 24 post-exercise.

    Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).

  61. Analysis of the metabolic parameters by capillary sampling_AEPCap 72

    Time frame: AEP group: at 72 hours post-exercise.

    Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).

  62. Analysis of the metabolic parameters by capillary sampling_CEPCap before

    Time frame: CEP group: during the first training session

    Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).

  63. Analysis of the metabolic parameters by capillary sampling_CEPCap 2w

    Time frame: CEP group: every morning up to two weeks.

    Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).

  64. Analysis of the metabolic parameters by capillary sampling_CEPCap end

    Time frame: CEP group: at the end of training sessions up to two weeks.

    Capillary sampling (prick sampling) to analysis metabolic parameters at systemic blood level will be performed during the first, in-hospital, training session and further will be continued at home, self-managed by the patient who will have to measure glycaemia and ketones every morning (finger prick sampling) and after each training sessions (earlobe prick sampling).

Other outcomes

  1. Physical Activity Questionnaire

    Time frame: Within one month of the enrollment

    Patient's life style will be investigated using the short version of Physical Activity Questionnaire

  2. MeDiet questionnaire

    Time frame: Within one month of the enrollment

    Patient's life style will be investigated using the short version of MeDiet questionnaire

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Registry information

Acronym: Agility

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2022
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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