- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04676009
Feasibility of an Acute Physical Exercise Before Treatment Infusion for Metastatic Lung Cancer Patients (ERICA)
Feasibility of an Acute Physical Exercise Before Immunotherapy and Chemotherapy Infusion for Metastatic Non-small-cell Lung Cancer Patients: Protocol ERICA Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Manon Gouez
- Phone Number: +33478782897
- Email: manon.gouez@lyon.unicancer.fr
Study Contact Backup
- Name: Olivia Pérol
- Phone Number: 0478782897 +334478782897
- Email: olivia.perol@lyon.unicancer.fr
Study Locations
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-
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Lyon, France, 69008
- Centre Leon Berard
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 80 years old,
- Having a newly metastatic non-small-cell lung cancer (NSCLC) without an EGFR/ALK alteration diagnosis,
- Being scheduled to receive a 1st line intravenous chemotherapy (Cisplatin and Pemetrexed or Carboplatin and Pemetrexed or Taxol and Carboplatin), and immunotherapy (monoclonal anti-PD-1 and anti-PD-L1 antibodies : Pembrolizumab) treatment NB : patients who have previously received one or more treatments other than chemotherapy (e.g. targeted therapy) and must start their first chemotherapy are eligible,
- Treated in Centre Leon Berard,
- Having an Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2,
- Being voluntary and available to get involved throughout the study duration,
- Being able to engage in Physical Activity with a medical certificate attested by one of the investigators clinical oncologist or the referring oncologist,
- Affiliated with a social security scheme,
- Having dated and signed an informed consent.
- Able to read, write and understand French
Exclusion Criteria:
- Patient with unstable bone metastases or unconsolidated pathologic fractures, Having a central nervous system impairment with neurological disorder avoids the physical exercise practice on a cycle ergometry,
- Personal history or co-existence of another primary cancer (except of in situ cancer regardless of the site and/or basal cell skin cancer and/or cancer in complete remission for more than 5 years),
- Having severe undernutrition defined according to the Haute Autorité de Santé (i.e. , for an adult aged ≥18 years and < 70 : BIM ≤ 17 or weight loss ≥ 10% in 1 month or ≥15% in 6 months or ≥ 15% compared to the usual weight before the disease diagnosis or albuminemia < 30 g/l ; for an adult aged ≥70 years : BIM < 18 or weight loss ≥ 10% in 1 month or ≥15% in 6 months or an albuminemia < 30 g/l),
- Having a severe amenia (hemoglobin ≤ 8 g/dl) during the 30 last days prior inclusion,
- Presenting cardiovascular history or any cardiovascular risk: chronic coronary (or poorly balanced), artery disease, cardiac arrhythmia, symptomatic heart disease, uncontrolled or untreated hypertension, heart attack diagnosed within the last 6 months, coronary angioplasty with or without stent less than 6 months old, coronary artery bypass surgery less than 12 months old, history of poorly balanced type 2 diabetes,
- In case of diabetes: Glycated hemoglobin (HbA1c) > 7% (in the last 3 months),
- Stage IV Chronic Obstructive Pulmonary Disease (FEV1 < 30%),
- Patient with a contraindication to the proposed physical exercise in the study (orthopedic disorder likely to impede walking and pedaling such as disabling coxarthrosis or gonarthrosis, operated or not),
- Already included in a PA study,
- Cannot be followed for medical, social, family, geographical or psychological reasons, for the duration of the intervention (3 months) and then for the duration of the post-intervention follow-up (3 months),
- Patient under legal protection measure (under guardianship, curatorship, safeguard of justice),
- Deprived of liberty by judicial or administrative decision,
- Pregnant patient.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise arm :
Patient randomized to the Exercise arm will receive physical activity recommendations at inclusion and nutritional assessment will be carried out during the first and last treatment cure. Patients will receive an acute physical exercise just before immunotherapy and chemotherapy infusion.They will have a home walking program and will have to wear an activity tracker during the 3 months of intervention. 3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place before exercise (1), after exercise (2) and 12 hours after the start of treatment (3). |
Patients will receive physical activity recommendations at inclusion. At each treatment cure, patients will receive pre-exercise nutritional recommendations and an acute physical exercise prior to immunotherapy and chemotherapy. The acute physical exercise will last 35 minutes and will be intermittent and individualized based on the results obtained by the patient during an endurance test on a ergocyle performed prior to treatment. 3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place before exercise (1), after exercise (2) and 12 hours after the start of treatment (3). A nutritional assessment will be carried out during the first and last treatment cure. They will also benefit a home walking program. These patients will have to wear an activity tracker tracker during all intervention (3 months). They will have a phone follow-up every 10 days (± 3 days) after each treatment cure for the study duration. |
No Intervention: Control arm
Patients will receive physical activity recommendations at inclusion and a nutritional assessment will be carried out during the first and last treatment cure. They will receive the usual care and standard treatment protocol (immunotherapy and chemotherapy). 3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment (3). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Investigate the feasibility of an acute physical exercise during the immunotherapy/chemotherapy preinfusion
Time Frame: 3 months
|
Ratio of the number of acute physical exercise sessions immunotherapy/chemotherapy preinfusion performed by"exercise" group patient / number of acute physical exercise sessions planned
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Investigate the physical activity fitness (sub-maximum endurance test)
Time Frame: Baseline, 3 months
|
Sub-maximum endurance test on an ergocycle
|
Baseline, 3 months
|
Investigate the lower strength muscular function change
Time Frame: Baseline, 3 months, 6 months
|
Maximum isometric force of the knee extensors
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Baseline, 3 months, 6 months
|
Investigate the maximum isometric upper limb strength change
Time Frame: Baseline, 3 months, 6 months
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Hand dynamometer
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Baseline, 3 months, 6 months
|
Investigate the Physical Activity level change
Time Frame: Baseline, 3 months, 6 months
|
The PA level will be measured by the Godin Leisure-Time Physical Activity Questionnaire (GLTAPQ).
The GLTAPQ is a 4-item self-administered questionnaire with the first three questions designed to obtain information on the number of times an individual engages in light, moderate and intense "leisure-time PA" periods of at least 15 minutes during a typical week.
The scoring of the GSLTPAQ is the "LSI" (Leisure Score Index) is obtained using the following formula: (light PA frequency × 3) + (moderate PA frequency × 5) + (vigorous PA frequency × 9).
People with a moderate to high LSI ≥ 24 are classified as active, while people reporting a moderate to high LSI ≤ 23 are classified as insufficiently active (estimated energy expenditure < 14 Kcal/kg/week).
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Baseline, 3 months, 6 months
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Investigate the patient anthropometrics change
Time Frame: Baseline, 3 months, 6 months
|
Weight in kilograms
|
Baseline, 3 months, 6 months
|
Investigate the patient anthropometrics change
Time Frame: Baseline, 3 months, 6 months
|
Hip circumference in centimeters
|
Baseline, 3 months, 6 months
|
Investigate the patient anthropometrics change
Time Frame: Baseline, 3 months, 6 months
|
Waist circumference in centimeters
|
Baseline, 3 months, 6 months
|
Investigate the patient anthropometrics change
Time Frame: Baseline, 3 months, 6 months
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BMI (weight/height²)
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Baseline, 3 months, 6 months
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Investigate the patient health-related quality of life change
Time Frame: Baseline, 3 months, 6 months
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Quality of life will be measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ-C30).
Quality of life specific to lung cancer will be assessed by the 13-item module: The Quality Of Life Questionnaire - Lung Cancer 13 (QLQ-LC13).
The QLQ-LC13 self-questionnaire is an additional measure of the symptoms and side effects experienced by lung cancer patients who receive non-surgical treatment.
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Baseline, 3 months, 6 months
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Investigate the patient health-related quality of life specific to lung cancer change
Time Frame: Baseline, 3 months, 6 months
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Quality of life specific to lung cancer will be assessed by the 13-item module: The Quality Of Life Questionnaire - Lung Cancer 13 (QLQ-LC13).
The QLQ-LC13 self-questionnaire is an additional measure of the symptoms and side effects experienced by lung cancer patients who receive non-surgical treatment.
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Baseline, 3 months, 6 months
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Investigate the fatigue change
Time Frame: Baseline, 3 months, 6 months
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Fatigue will be assessed by the EORTC-QLQ module measuring cancer-related fatigue (EORTC QLQ-FA12).
This self-questionnaire includes 12 items that assess physical, cognitive and emotional fatigue related to cancer.
Participants will respond on a Likert scale ranging from "not at all" to "a lot".
All scores will be transformed into a scale from 0 to 100, with a higher score indicating a higher degree of fatigue.
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Baseline, 3 months, 6 months
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Investigate the sleep quality change
Time Frame: Baseline, 3 months, 6 months
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The perceived quality of sleep is assessed by the Insomnia Severity Index (ISI) which measures the severity of insomnia.
The questionnaire consists of 7 items rated on a 5-point scale ranging from 0 ("none") to 4 ("very severe").
This self-questionnaire makes it possible to evaluate the severity of the patient's sleep difficulties (initial, maintenance, morning insomnia), the degree of sleep dissatisfaction, the level of interference with daily functioning, the degree of appearance of sleep difficulties and the level of anxiety related to insomnia.
The total score of the items varies between 0 and 28.
A high score indicates greater sleep difficulties.
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Baseline, 3 months, 6 months
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Investigate the impact of social vulnerability
Time Frame: Baseline
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Social vulnerability will be assessed by the EPICES score (Evaluation de la Précarité et des Inégalités de santé dans les Centres d'Examens de Santé).
By adding up the points of the 11 binary questions ("Yes"/"No") of the self-questionnaire we obtain the so-called EPICES score.
This quantitative score varies from 0 "no precariousness" to 100 "highest precariousness".
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Baseline
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Investigate the muscle mass and sarcopenia
Time Frame: Baseline, 3 months, 6 months
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CT scans
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Baseline, 3 months, 6 months
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Investigate the immune biomarkers change
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3). The following immune biomarkers will be assay : Natural Killer cells, B lymphocytes, T lymphocytes, monocytes, sub-populations of dendritic cells on frozen PBMC |
Baseline and 3 months
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Investigate the Activin change (inflammation biomarkers)
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
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Baseline and 3 months
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Investigate the TNF-alpha change (inflammation biomarkers)
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
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Baseline and 3 months
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Investigate the IL-1béta change (inflammation biomarkers)
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
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Baseline and 3 months
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Investigate the IL-6 change (inflammation biomarkers)
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
|
Baseline and 3 months
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Investigate the Follistatin (inflammation biomarkers)
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
|
Baseline and 3 months
|
Investigate the GDF5 (BMP14) (inflammation biomarkers)
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
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Baseline and 3 months
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Investigate the GDF15 (inflammation biomarkers)
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
|
Baseline and 3 months
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Investigate the IL-10 (inflammation biomarkers)
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
|
Baseline and 3 months
|
Investigate the IL-15 (inflammation biomarkers)
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
|
Baseline and 3 months
|
Investigate the NH3 (inflammation biomarkers)
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
|
Baseline and 3 months
|
Investigate the Aminogramme (inflammation biomarkers)
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
|
Baseline and 3 months
|
Investigate the CRP (inflammation biomarkers)
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
|
Baseline and 3 months
|
Investigate the IFN-gamma change (inflammation biomarkers)
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
|
Baseline and 3 months
|
Investigate the Cortisol change (inflammation biomarkers)
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
|
Baseline and 3 months
|
Investigate the Myostatin change (inflammation biomarkers)
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
|
Baseline and 3 months
|
Investigate the Advanced oxidation protein products (AOPP) change
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
|
Baseline and 3 months
|
Investigate the Superoxide dismutase (SOD) change
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
|
Baseline and 3 months
|
Investigate the catalase (CAT) change
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
|
Baseline and 3 months
|
Investigate the malondialdehyde (MDA) change
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3). The following biomarkers will be assay : Advanced oxidation protein products (AOPP), malondialdehyde (MDA), Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), Xanthine oxidase (XO), and Myeloperoxidase (MPO). |
Baseline and 3 months
|
Investigate the glutathione peroxidase (GPX) change
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3). The following biomarkers will be assay : Advanced oxidation protein products (AOPP), malondialdehyde (MDA), Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), Xanthine oxidase (XO), and Myeloperoxidase (MPO). |
Baseline and 3 months
|
Investigate the Xanthine Myeloperoxidase (MPO) change
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3). The following biomarkers will be assay : Advanced oxidation protein products (AOPP), malondialdehyde (MDA), Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), Xanthine oxidase (XO), and Myeloperoxidase (MPO). |
Baseline and 3 months
|
Investigate the Xanthine oxidase (XO) change
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3). The following biomarkers will be assay : Advanced oxidation protein products (AOPP), malondialdehyde (MDA), Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), Xanthine oxidase (XO), and Myeloperoxidase (MPO). |
Baseline and 3 months
|
Proportion of patients who have severe toxicity (grade >2)
Time Frame: Up to 3 months
|
Occurence of severe toxicity (grade > 2) according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE).
Number of delayed or cancelled treatment sessions and relative dose-intensity (RDI) for patients with grade ≥ 3 chemotherapy-related toxicities, calculated as the ratio of the "delivered" dose-intensity to the "expected" dose-intensity.
|
Up to 3 months
|
Progression free survival
Time Frame: 6 months
|
Period from the date of randomization to the date of event defined as disease progression or death from any cause
|
6 months
|
Acceptability of the study
Time Frame: 3 months
|
Ratio of the number of patients included / number of eligible patients
|
3 months
|
Tracker activity acceptability
Time Frame: 3 months
|
Number of days the activity tracker is worn / number of days in the programme
|
3 months
|
Safety of the intervention
Time Frame: 3 months
|
Number, type and timing of adverse events due to program
|
3 months
|
Adherence of the intervention
Time Frame: 3 months and 6 months
|
number of steps at home realized / number of steps at home prescribed (only in the intervention arm)
|
3 months and 6 months
|
Investigate the Physical Activity level change
Time Frame: Baseline, 3 months and 6 months
|
Daily number of step prescription (only in the intervention arm)
|
Baseline, 3 months and 6 months
|
Investigate the glucose change
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
|
Baseline and 3 months
|
Investigate the insulin change
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
|
Baseline and 3 months
|
Investigate the lactat change
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
|
Baseline and 3 months
|
Investigate the PCR change
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
|
Baseline and 3 months
|
Investigate the HIF-1 change
Time Frame: Baseline and 3 months
|
3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place: for the exercise group: before exercise (1), after exercise (2) and 12 hours after the start of treatment (3); and for the control group: 40 min before the administration of treatments (1), just before the administration of treatments (2) and 12 hours after the start of treatment(3).
|
Baseline and 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maurice Pérol, MD, Centre Leon Berard
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERICA
- ET20000185 (Other Identifier: Sponsor's ID)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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National Cancer Institute (NCI)TerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
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National Cancer Institute (NCI)Active, not recruitingStage IIIA Lung Non-Small Cell Cancer AJCC v7 | Advanced Lung Non-Squamous Non-Small Cell Carcinoma | Metastatic Lung Non-Squamous Non-Small Cell Carcinoma | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IV Lung Non-Small Cell Cancer AJCC v7 | Stage III Lung Non-Small Cell Cancer AJCC...United States
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University of Southern CaliforniaNational Cancer Institute (NCI); Society of Thoracic RadiologyActive, not recruitingStage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
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National Cancer Institute (NCI)CompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
Clinical Trials on Exercise arm :
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University of Nove de JulhoEnrolling by invitationPeripheral Arterial DiseaseBrazil
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Case Western Reserve UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMultiple SclerosisUnited States
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University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
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University of AlcalaRecruitingAxillary Web SyndromeSpain
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University of California, San FranciscoNational Cancer Institute (NCI)Completed
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National Taiwan University HospitalCompletedSystematically Intermittent Arm Exercise for Improving Maturation of Hemodialysis Arteriovenous ShuntTaiwan
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University of California, IrvineEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
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Henry Ford Health SystemTerminated
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University of IowaCompletedKidney Failure, ChronicUnited States
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Baylor Research InstituteCompleted