Terminé

ERICAFeasibility of an Acute Physical Exercise Before Immunotherapy and Chemotherapy Infusion for Metastatic Non-small-cell Lung Cancer Patients: Protocol ERICA Study

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Ce qui est testé

Exercise arm :

Autre
Qui peut participer

Néoplasmes bronchiques+11

+ Carcinome du poumon non à petites cellules

+ Carcinome bronchogénique

De 18 à 80 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Soins de support

Interventionnel
Date de début : janvier 2021
Voir le détail du protocole

Résumé

Sponsor principalCentre Leon Berard
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

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.

Titre officielFeasibility of an Acute Physical Exercise Before Immunotherapy and Chemotherapy Infusion for Metastatic Non-small-cell Lung Cancer Patients: Protocol ERICA Study
NCT04676009
Sponsor principalCentre Leon Berard
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

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.
Détails du design

26 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Soins de support

Cette étude teste des approches visant à améliorer le confort, le bien-être ou la qualité de vie des personnes atteintes d'une maladie, notamment en aidant à mieux gérer les symptômes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

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

Néoplasmes bronchiquesCarcinome du poumon non à petites cellulesCarcinome bronchogéniqueNéoplasmes pulmonairesMaladies pulmonairesMétastase de néoplasieNéoplasmes par siteNéoplasmesProcessus NéoplasiquesProcessus pathologiquesMaladies des voies respiratoiresNéoplasmes des Voies RespiratoiresConditions pathologiques, signes et symptômesNéoplasmes thoraciques

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.
Groupes de traitement
Objectifs de l'étude

Un seul groupe d'intervention est désigné dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
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).

Objectifs 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

Suspendu

Centre Léon Bérard

Lyon, FranceOuvrir Centre Léon Bérard dans Google Maps
Terminé1 Centres d'Étude
ERICA | Feasibility of an Acute Physical Exercise Before Immunotherapy and Chemotherapy Infusion for Metastatic Non-small-cell Lung Cancer Patients: Protocol ERICA Study | PatLynk