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| ID | Type | Description | Link |
|---|---|---|---|
| ET20000185 | Other Identifier | Sponsor's ID |
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| Name | Class |
|---|---|
| Claude Bernard University | OTHER |
| Cancer Research Center of Lyon | OTHER |
| Hospices Civils de Lyon | OTHER |
| Inter-university Laboratory of Human Movement Biology |
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Because of metastatic Non-Small Cell Lung Cancer (mNSCLC) and its treatments, patients suffer from numerous symptoms such as dyspnea, muscle atrophy, pain, fatigue, loss of appetite, altered physical condition and lung function, which may further impair the patient's overall condition. Nevertheless, it has been suggested that physical exercise could improve response to treatment at the clinical level due to its known effects on the immune system. Moreover, preclinical studies have shown that exercise performed during chemotherapy administration could result in physiological benefits such as improved intra-tumoral infusion and drug delivery. The ERICA study aims to assess the feasibility of an acute physical exercise immediately before immunotherapy and chemotherapy administration in patients with mNSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise arm : | Experimental | 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). |
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| Control arm | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise arm : | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate the feasibility of an acute physical exercise during the immunotherapy/chemotherapy preinfusion | Ratio of the number of acute physical exercise sessions immunotherapy/chemotherapy preinfusion performed by"exercise" group patient / number of acute physical exercise sessions planned | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate the physical activity fitness (sub-maximum endurance test) | Sub-maximum endurance test on an ergocycle | Baseline, 3 months |
| Investigate the lower strength muscular function change | Maximum isometric force of the knee extensors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maurice Pérol, MD | Centre Leon Berard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Léon Bérard | Lyon | 69008 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35393316 | Derived | Gouez M, Perol O, Perol M, Caux C, Menetrier-Caux C, Villard M, Walzer T, Delrieu L, Saintigny P, Marijnen P, Pialoux V, Fervers B. Effect of acute aerobic exercise before immunotherapy and chemotherapy infusion in patients with metastatic non-small-cell lung cancer: protocol for the ERICA feasibility trial. BMJ Open. 2022 Apr 7;12(4):e056819. doi: 10.1136/bmjopen-2021-056819. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| UNKNOWN |
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| Baseline, 3 months, 6 months |
| Investigate the maximum isometric upper limb strength change | Hand dynamometer | Baseline, 3 months, 6 months |
| Investigate the Physical Activity level change | 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). | Baseline, 3 months, 6 months |
| Investigate the patient anthropometrics change | Weight in kilograms | Baseline, 3 months, 6 months |
| Investigate the patient anthropometrics change | Hip circumference in centimeters | Baseline, 3 months, 6 months |
| Investigate the patient anthropometrics change | Waist circumference in centimeters | Baseline, 3 months, 6 months |
| Investigate the patient anthropometrics change | BMI (weight/height²) | Baseline, 3 months, 6 months |
| Investigate the patient health-related quality of life change | 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. | Baseline, 3 months, 6 months |
| Investigate the patient health-related quality of life specific to lung cancer change | 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. | Baseline, 3 months, 6 months |
| Investigate the fatigue change | 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. | Baseline, 3 months, 6 months |
| Investigate the sleep quality change | 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. | Baseline, 3 months, 6 months |
| Investigate the impact of social vulnerability | 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". | Baseline |
| Investigate the muscle mass and sarcopenia | CT scans | Baseline, 3 months, 6 months |
| Investigate the immune biomarkers change | 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 |
| Investigate the Activin change (inflammation biomarkers) | 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 TNF-alpha change (inflammation biomarkers) | 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-1béta change (inflammation biomarkers) | 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-6 change (inflammation biomarkers) | 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 Follistatin (inflammation biomarkers) | 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) | 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 GDF15 (inflammation biomarkers) | 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-10 (inflammation biomarkers) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | Ratio of the number of patients included / number of eligible patients | 3 months |
| Tracker activity acceptability | Number of days the activity tracker is worn / number of days in the programme | 3 months |
| Safety of the intervention | Number, type and timing of adverse events due to program | 3 months |
| Adherence of the intervention | 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 | Daily number of step prescription (only in the intervention arm) | Baseline, 3 months and 6 months |
| Investigate the glucose change | 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 | 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 | 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 | 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 | 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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |