ERICAFeasibility of an Acute Physical Exercise Before Immunotherapy and Chemotherapy Infusion for Metastatic Non-small-cell Lung Cancer Patients: Protocol ERICA Study
Exercise arm :
Néoplasmes bronchiques+11
+ Carcinome du poumon non à petites cellules
+ Carcinome bronchogénique
Soins de support
Résumé
Date de début de l'étude : 21 janvier 2021
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.26 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Soins de support
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 80 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site